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PMA Approvals
Three devices have been approved since the last panel meeting on August 1-2, 2002.
・On October 18, 2002, FDA approved P970043, Supplement 10, for the Alcon LADARVision 4000 CustomCorneaR, indicated for wavefront-guided LASIK for the reduction or elimination of myopia up to -7.00 D with less than -0.50 D of astigmatism at the spectacle plane.
・On February 25, 2003, FDA approved P990027, Supplement 4, for the Bausch and Lomb TECHNOLASR 217A Excimer Laser System, indicated for LASIK treatments for the reduction or elimination of low-to-moderate naturally-occurring hyperopia of +1.00 to +4.00 diopters with or without refractive astigmatism up to +2.00 diopters.
・On May 23, 2003, the FDA approved P930016, Supplement 16, for the VISX Star S4 WaveScanR excimer laser for wavefront-guided laser in situ keratomileusis (LASIK) for the reduction or elimination of myopic astigmatism up to -6.00 diopters (D) mean refractive spherical equivalent (MRSE) with cylinder between 0.00 D and -3.00 D at the spectacle plane

ML 開催日 議題 備考
     
  2016.  
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果/Minutes】 [] Yes=,No=,保留=
 
  2015.11.05 The committees will discuss the risks and benefits of the systemic fluoroquinolone antibacterial drugs for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis in patients who have chronic obstructive pulmonary disease, and uncomplicated urinary tract infections in the context of available safety information and the treatment effect of antibacterial drugs in these clinical conditions. 
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果/Minutes】 [] Yes=,No=,保留=
 
1490 2015.01.22 (NDAs) 207-500 and 207-501, isavuconazonium sulfate capsules and isavuconazonium sulfate for injection, sponsored by Astellas Pharma Global Development, Inc., respectively for the proposed indications of treatment of invasive aspergillosis and mucormycosis. 
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果/Minutes】 [侵襲性アスペルギルス症に有効性と安全性を示したか?] Yes=11,No=0,保留=0 [侵襲性ムーコル症に有効性と安全性を示したか?] Yes=8,No=2,保留=1
isavuconazonium
  2014.12.05 (NDA) 206494 for ceftazidime-avibactam for injection, submitted by Cerexa Inc., for the proposed indications of: Complicated Intra-abdominal Infections, Complicated Urinary Tract Infections, including Acute Pyelonephritis and Limited Use Indication: Aerobic Gram-negative Infections with Limited Treatment Options. 
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果/Minutes】 [] Yes=,No=,保留=
ceftazidime-avibactam
  2014.12.04 The committee will discuss issues related to clinical development programs and clinical trial designs for antibacterial products for the treatment of patients with serious bacterial infections for which there are limited or no therapeutic options. 
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果/Minutes】 [] Yes=,No=,保留=
 
1442 2014.03.31/午前 The committee will discuss new drug applications (NDAs) 205-435 and 205-436, tedizolid phosphate tablets and tedizolid phosphate injection, submitted by Trius Therapeutics, respectively, for the proposed indication of treatment of acute bacterial skin and skin structure infections. 
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果/Minutes】 [有効性と安全性を実証したか?] Yes=14,No=0,保留=0
tedizolid
1442 2014.03.31/午後 The committee will discuss NDA 021-883, dalbavancin hydrochloride for intravenous injection, submitted by Durata Therapeutics International B.V., for the proposed indication of treatment of acute bacterial skin and skin structure infections. 
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果/Minutes】 [有効性と安全性を実証したか?] Yes=12,No=0,保留=0
dalbavancin
1428 2013.10.18 (NDA) 204684, miltefosine capsules, submitted by Paladin Therapeutics, Inc., for the proposed indication of treatment of patients with visceral (involving internal organs), mucosal (involving areas such as inside the mouth and nose), and cutaneous (involving the skin) leishmaniasis, an infection caused by a parasite. 
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果/Minutes】 [ 内臓リーシュマニア症の有効性と安全性のデモは十分か?] Yes=15,No=1,保留=0  [皮膚リーシュマニア症の有効性と安全性のデモは十分か?] Yes=14,No=2,保留=0  [粘膜リーシュマニア症の有効性と安全性のデモは十分か?] Yes=13,No=3,保留=0
miltefosine
  2013.10.17 to discuss susceptibility interpretive criteria for systemic antibacterial drugs and for dosing recommendations in product labeling. We will seek input on the role of pharmacokinetic data in setting susceptibility interpretive criteria. We will also discuss revising dosing recommendations in product labeling based on pharmacokinetic data and clinical safety and efficacy data. 
※資料Briefing Information | Slides
 
  2012.11.29 (NDA) 22407, VIBATIV (telavancin hydrochloride) sterile powder for injection, submitted by Theravance, Inc., for the requested indication of nosocomial pneumonia (pneumonia contracted by hospitalized patients), including ventilator-associated pneumonia (VAP), caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus (including methicillin-susceptible and -resistant isoloates) or Streptococcus pneumoniae (penicillin susceptible strains). 
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果/Minutes】 [] Yes=,No=,保留=
VIBATIV (telavancin)
1423 2012.11.28 NDA 204384, bedaquiline tablets, submitted by Janssen Therapeutics, Division of Janssen Products, LP. The proposed indication (use) for this product is for the treatment of patients with multi-drug resistant pulmonary tuberculosis. 
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果/Minutes】 [有効性] Yes=18,No=0,保留=0  [安全性] Yes=11,No=7,保留=0
bedaquiline
1413 2012.11.02 (BLA) 125346, raxibacumab injection, a humanized monoclonal antibody against protective antigen of Bacillis anthracis, by Human Genome Sciences, Inc. for the proposed indication of treatment of inhalational anthrax 
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果/Minutes】 [有効性] Yes=16,No=1,保留=1  [安全性] Yes=18,No=0,保留=0
raxibacumab
1419 2012.09.05 (NDA) 201688, tobramycin inhalation powder, application submitted by Novartis Pharmaceuticals Corporation, and the requested indication of management of cystic fibrosis patients infected with the bacterium Pseudomonas aeruginosa 
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果/Minutes】 [有効性と安全性は十分?] Yes=13,No=1,保留=0
tobramycin inhalation
  2012.04.04 levofloxacin for the treatment of pneumonic plague in humans. Johnson and Johnson Pharmaceutical Research and Development, LLC (on behalf of Janssen Pharmaceuticals, Inc.) has submitted efficacy supplements for Levaquin (levofloxacin) tablets, injection, and oral solution (NDA 20-634, NDA 20-635, and NDA 21-721, respectively) for treatment of pneumonic plague. Efficacy data for levofloxacin is based on treatment in an animal model of plague. Safety and other supportive information is derived from clinical studies and post-marketing experience in humans. 
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果/Minutes】 [] Yes=,No=,保留=
levofloxacin 
  2012.04.03 ciprofloxacin for the treatment of pneumonic plague in humans. The National Institute of Allergy and Infectious Diseases (NIAID) has submitted efficacy data for ciprofloxacin, based on treatment in an animal model of plague. Safety and other supportive information is derived from clinical studies and post-marketing experience in humans. 
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果/Minutes】 [] Yes=,No=,保留=
ciprofloxacin
  2012.04.02 MedKit containing doxycycline to be taken in the event of anthrax exposure. Issues such as the feasibility of an FDA-approved MedKit as a public health strategy, the role of personal MedKits, home stockpiling, and interfaces of home readiness with public health systems, will be raised in the course of the discussions. The Biomedical Advanced Research and Development Authority will propose a possible plan for a step-wise development program for MedKits containing oral doxycycline hyclate. 
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果/Minutes】
MedKit doxycycline
  2011.11.04 clinical trial design issues in the development of antibacterials for the treatment of Hospital-Acquired Bacterial Pneumonia (HABP), including Ventilator-Associated Bacterial Pneumonia (VABP) and the draft document entitled "Guidance for Industry, Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment", published November 2010 (see FDA Web site: Clinical/Antimicrobial Guidances1). 
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果/Minutes】 [] Yes=,No=,保留=
 
  2011.11.03 clinical trial design issues for the development of antibacterials for the treatment of Community-Acquired Bacterial Pneumonia (CABP) and the draft document entitled "Guidance for Industry, Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment", published March 2009 (see FDA Web site: Clinical/Antimicrobial Guidances1). 
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果/Minutes】 [] Yes=,No=,保留=
 
1373 2011.04.05 (NDA) 20-1699, for fidaxomicin tablets, submitted by Optimer Pharmaceuticals, Inc., for the requested indication of treatment of adults with Clostridium difficile infection (CDI), also known as Clostridium difficile-associated diarrhea (CDAD), and prevention of recurrences.
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果/Minutes】 [有効性と安全性が提示されたか?]Y=13,N=0,保留=0
fidaxomicin
1356 2010.09.07 (NDA) 200-327, for ceftaroline fosamil for injection, submitted by Cerexa, Inc., and the requested indications of: (1) treatment of adults with community acquired bacterial pneumonia (CABP); and (2) complicated skin and skin structure infections (cSSSI). The morning session will be devoted to discussing the CABP indication, and the afternoon session to discussing the cSSSI indication.
※資料Briefing Information | Slides | 議事録Transcript1 - Transcript2 | 【審議結果/Minutes】 [CABPについて有効性と安全性が提示されたか?]Y=21,N=0,保留=0 [cSSSIについて有効性と安全性が提示されたか?]Y=18,N=0,保留=0 
ceftaroline fosamil
  2010.04.29 (NDA) 21-242, artesunate rectal suppositories, submitted by the World Health Organization, for the proposed use as a single dose for the initial treatment of patients with acute malaria who cannot take medication by mouth and for whom injectable treatment is not available. 
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果/Minutes】 [坐薬100mgでの承認可否] Yes=13,No=2,保留=0 [坐薬400mgでの承認可否] Yes=1,No=14,保留=0
artesunate
1344 2009.12.10 (NDA) 050-814, inhaled aztreonam, Gilead Sciences, Inc., for the proposed indication of improvement of respiratory symptoms and pulmonary function in cystic fibrosis patients with Pseudomonas aeruginosa, a bacterial infection. 
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果/Minutes】[有効性と安全性]Y=15,N=2,保留=0
inhaled aztreonam
  2009.12.09 endpoints and other clinical trial design issues in the development of antibacterial products for the treatment of community-acquired bacterial pneumonia. 
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果/Minutes】
 
1413 2009.10.27 (BLA) 125349, for raxibacumab injection, manufactured by Human Genome Sciences, Inc., proposed for the treatment of inhalational anthrax disease(炭疽菌). 
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果/Minutes】 [動物モデルでのraxibacumabの効果が人体での反応を予測可能か] Yes=16,No=7,保留=1  [raxibacumabは炭疽菌での抗菌剤の効果を低減しないか?] Yes=10,No=11,保留=3
raxibacumab
  2009.10.26 updating susceptibility test information in systemic antibacterial drug product labeling. 
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果/Minutes】
 
  2009.06.03 抗結核薬の開発 
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果/Minutes】
抗結核薬
  2009.06.02 (NDA) 22-398, cethromycin oral tablets, sponsored by Advanced Life Sciences, for the proposed indication of outpatient treatment of adults with mild to moderate community-acquired pneumonia 
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果/Minutes】[安全性] Yes=11,No=3,保留=1  [有効性] Yes=3,No=11,保留=1
cethromycin
  2008.12.03 NDA) 22-268, artemether 20 mg/lumefantrine 120mg, sponsored by Novartis Pharmaceuticals Corporation, for the proposed indication of treatment of acute, uncomplicated malaria infection due to Plasmodium falciparum or mixed infections including P. falciparum. 
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果/Final Minutes】 [P. falciparum感染患者で有効性を証明したか?] Yes=18,No=0,保留=0 [P. falciparum感染患者で安全性を証明したか?] Yes=17,No=1,保留=0 [P. falciparum and P. vivax双方に感染した患者で有効性と安全性を証明したか?] Yes=9,No=8,保留=1
artemether 20 mg/lumefantrine 120mg
  2008.11.20 NDA 022-269, iclaprim, Arpida AG, proposed for the treatment of complicated skin and skin structure infection 
※資料Briefing Information | Slides | 【審議結果/Final Minutes】 Yes=2,No=16(QT延長、相互作用、毒性の妊婦への影響が問題視)
iclaprim
1329 2008.11.19 (1) (NDA) 022-110, telavancin powder for reconstitution and intravenous administration, Theravance, Inc., proposed for the treatment of complicated skin and skin structure infection, and (2) NDA 022-153, oritavancin, Targanta Therapeutics Corp., proposed for the treatment of complicated skin and skin structure infection.  
※資料Briefing Information | Slides | 【審議結果/Final Minutes(1)Telavancin】 Yes=21,No=5(腎毒性、催奇形性、QT延長の問題はラベル表示と使用制限) 【審議結果/Final Minutes(2)oritavancin】 [cSSSIの有効性と安全性]Yes=8,No=10
telavancin/oritavancin
  2008.11.18 複雑性皮膚および皮膚構造感染(complicated skin and skin structure infections.)(cSSSIs) の非劣勢マージン 
※資料Briefing Information | Slides | 【審議結果/Final Minutes】 (非劣勢試験をcSSSIの適応申請で受け入れるか?)Yes=20,No=0(10%程度のmarginが必要)
Dalbavancin/Linezolid
  2008.07.16 NDA) 022-171, doripenem powder for reconstitution and intravenous administration, Johnson and Johnson Pharmaceutical Research and Development, LLC, proposed for the treatment of nosocomial pneumonia, including ventilator-associated pneumonia. 
※資料Briefing Information | 【審議結果/Final Minutes】
doripenem
  2008.04.1/2 市中肺炎の製品開発および臨床試験デザイン 
※資料Briefing Information | 【審議結果/Minutes】
 
  2007.04.12 Shiga toxin-producing bacteria予防および治療薬の臨床研究デザイン※cαStx1/cαStx2[Thallion Pharmaceuticals ] 
※資料Briefing Information | 【審議結果/Minutes】
 
  2006.12.14/15 承認済医薬品KETEK (telithromycin), (NDA) 21-144, with the current indications of: Acute bacterial exacerbations of chronic bronchitis, acute bacterial sinusitis, and community acquired pneumonia, manufactured by Sanofi-Aventis.の全般的リスク・ベネフィット 
※資料Briefing Information | 【審議結果/Summary Minutes】 1)リスクを上回るベネフィットがあるか? a)市中肺炎,Yes=16,No=3  b)慢性気管支炎の急性憎悪,Yes=2,No=17  c)細菌性急性鼻炎,Yes=2,No=17 2-3)略
telithromycin
  2006.09.11 (NDAs) 21-931, garenoxacin mesylate tablets, 400mg and 600 mg, and NDA 21-932, intravenous garenoxacin mesylate, 400 mg (200 milliliters (mL) of 2 mg/mL) and 600 mg (300 mL of 2 mg/mL), proposed trade name GENINAX, submitted by Schering Corp., for the proposed treatment indications of acute bacterial exacerbation of chronic bronchitis, acute bacterial sinusitis, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections, and complicated intra-abdominal infections. ※→キャンセル garenoxacin
  2006.09.12 (sNDA) 21-158/S-006, Factive (gemifloxacin mesylate) Tablets, submitted by Oscient Pharmaceuticals Corp., for the proposed treatment of acute bacterial sinusitis.
※資料Briefing Information | 【審議結果/Minutes】  1)有効性=Yes=4,No=10 2)Risk/Benefitは受入れ可能か? Yes=2,No=11,保留=1
 
  2006.03.06 Cubist Cubicin sNDA For Endocarditis & Bacteremia※Cubist社のcyclic lipopeptide製剤daptomycinは黄色ブドウ球菌等複雑な皮膚と皮膚構造感染症に使われるが、今回心内膜炎[endocarditis]を含む菌血症[bacteremia]の適応症追加を審議。前回2004.10.14では否決された。; Brief Information
※【審議結果】S. aureus bacteremiaに対しては全員一致で承認勧告(実際25%がOff-labelで本適応に使用)。 しかし心内膜炎患者での有効性・安全性では5:4で票が割れた。
Cubicin(daptomycin)
  2004.10.14 Catheter-Related Bacteremia Clinical Trial Design
※ブドウ球菌[Staphylococcus aureus]による菌血症[Bacteremia]に関して。 FDAは1998年に菌血症に関する論議を開始し、1999年にカテーテル関連の菌血症のdraft guidance作成の審議を開始した。 2004.4.15,FDAと米国感染症学会共催でカテーテルの細菌感染症をテーマとするワークショップを開催。 dalbavancin(Vicuron社;半合成glycopeptide抗生物質)がP2完了し、その研究成果も発表、年内申請予定。 omiganan 1% gel(Strata Pharmaceuticals with Micrologix Biotech), a bactolysin cationic antimicrobial peptide,は中心静脈カテーテル法を施行した患者での血流感染予防の適応で開発中。 Cubicin (daptomycin; Cubist社とLilly社)は、ブドウ球菌による心内膜炎および菌血症に対するP3試験を実施中。 oritavancin(InterMune Pharmaceuticals社;Lilly社から2001年に全世界の権利取得)はglycopeptide抗生物質で菌血症に対する研究実施中。
※[審議結果]Pfizer, Vicuron and Cubistの3社はカテーテル関連血流感染の研究で患者確保とカテーテルからの培養データ取得の困難さを訴えたが、委員の大半が二つのblood culturesがブドウ球菌と同定した細菌感染患者から採取すべきとした。「An indication for treatment of primary bacteremia caused by Staphylococcus aureus」という適応名についても命名・グループ化など異論がでて、「不同意」との結論。
 
  2004.06.09 SSRI Antidepressant Effects On Infants/Pediatric Adverse Event Reporting
※妊娠中にSSRIを服用していた場合に、眼の先天異常や重大に症状を持つ新生児が出産するリスクがある。
※またBest Pharmaceuticals For Children Actに関連してGlaxoSmithKline’s Hycamtin (topotecan), Schering’s Temodar (temozolomide), Wyeth’s Effexor (venlafaxine), Bristol-Myers Squibb’s Monopril (fosinopril), Aventis’ Allegra (fexofenadine), Johnson & Johnson’s Duragesic (transdermal fentanyl), Alcon’s Ciloxan (ciprofloxacin) and Bayer’s Vigamox (moxifloxacin)の副作用情報が報告される。
 
  2004.05.10 Bristol Tequin (Gatifloxacin) For Recurrent Otitis Media(再発中耳炎) Tequin (Gatifloxacin)
  2004.05.11 Antiseptic Drug Product Efficacy Surrogate Endpoints
※臨床試験で効果判定におけるsurrogate markersとしての微生物エンドポイント
 
1176 2004.02.02 Antidepressant Risk Of Suicidality In Pediatric Patients
※2003.8にWyeth's Effexor (venalafaxine)のラベルに警告が追加。これはSSRI,norepinephrine-RIの小児臨床試験でhostility and suicide関連の副作用が発生したため。 GSK's Paxil (paroxetine)にも自殺増加のデータが発表。
Effexor (venalafaxine)
  2004.02.03 Pediatric Adverse Event Reports For Paxil, Celexa, Pravachol, and Navelbine
※the 2002 Best Pharmaceuticals for Children Actで指定された医薬品Paxil[GSK], Navelbine[GSK], Celexa[Forest], Pravachol[BMS]の小児副作用の報告が行われる
 
  2004.02.04 Cardiac Imaging Agents For Pediatric Population
 
  2003.10.30 Atopic Dermatitis Patient Cancer Recurrence Long-Term Monitoring
※アトピー性皮膚炎で局所用免疫抑制剤(Protopic (tacrolimus)[藤沢薬品]やElidel (pimecrolimus)[ノバルティス社])を服用している小児患者に長期癌登録
 
  2003.10.29 Atopic Dermatitis Drugs: HPA Suppression Risks In Pediatric Patients
※アトピー性皮膚炎の小児患者に局所用ステロイド使用時のHPA抑制リスク。Pfizer's Zyrtec and Accupril; Merck's Cozaar; AstraZeneca's Nolvadex, Orphan Medical's Busulfex and Bristol-Myers Squibb's Serzone.の副作用
 
  2003.10.28 Diabetic Foot Infection Clinical Trial Design For Antimicrobials(糖尿病性足病変感染症)
※1998.7にdraft guidanceが発行されており、Pfizer社Zyvox (linezolid)がグラム陽性菌による糖尿病性足病変感染症の適応を1998.7に承認。
※[審議結果]臨床試験に生検が必要など。
 
  2003.10.29 Antimicrobial Clinical Trial Design For Acute Bacterial Sinusitis(急性副鼻腔炎)
※Zithromax (azithromycin) が2003.3急性副鼻腔炎の追加適応申請、Ketek (telithromycin)も
※急性副鼻腔炎については前回1998.7に審議されていて抗菌剤の18適応についてのdraft guidanceが発行された。
※[審議結果]細菌の存在を診断する目的で鼻腔穿刺が必要など
 
  2003.6.11 Hyperbilirubinemia Epidemiology & Interventions
※通常Phototherapyによる治療が行われる新生児の高ビリルビン血症
 
  2003.6.12 Pediatric Adverse Event Reporting: Zoloft, Ditropan, Lipitor, Zocor
※小児用医薬品の試験を義務づけるBest Pharmaceuticals for Children Act(BPCA) - 関連記事−が昨2002年成立に伴う措置。 Pfizer's Zoloft (sertraline) and Alza’s Ditropan (oxybutynin)が副作用報告。 Pfizer's Lipitor (atorvastatin) and Merck’s Zocor (simvastatin)は中間報告
 
  2003.03.03 HIV Drug Development In Neonates
※現在承認のために要求されている新生児でのエイズ薬臨床試験は非人道的
現在米国内で生まれるHIV感染新生児は300-400に低下
 
  2003.03.04 GeneSoft Factive For Community Acquired Pneumonia, Chronic Bronchitis
※市中肺炎は18:0で承認勧告、慢性気管支炎は15-3-1。
※本剤は韓国LG Life Sciencesが創製、GSKが権利取得し1999.12申請したが2000.12FDA申請却下により契約解消。
Genesoftは2002.10北米・欧州の権利取得。不許可理由QTc interval、肝臓毒性、発疹の追加試験は終了
(gemifloxacin)
  2003.03.05 Pathogen List For Future Antimicrobial Drug Development  
  2003.01.08 Aventis Ketek Antibiotic Rereview
※CAPと急性副鼻腔炎に承認勧告(24,137例に基づく2回目Cmte)
※FDA Brief Information
telithromycin
  2003.01.09 Antimicrobial Ranking And Animal Drug Safety
※企業向け安全評価ガイダンスFDA Brief Information
 
  2002.11.20 Antimicrobial Drug Development Conference - Day 2  
  2002.11.19 Antimicrobial Drug Development Conference - Day 1  
  2002.07.11 Otitis Media Clinical Trial Design  
1286 2002.07.10 Artesunate Rectal Suppositories/capsules For Emergency Treatment Of Malaria by Swissmedic
※資料Briefing Information | Slides | 議事録Transcript -[pdf] -[word]【審議結果】全員一致でその有効性と安全性を支持
 
  2002.06.11 Proton Pump Inhibitor Pediatric Request Template; Priority List F  
  2002.02.20 Antimicrobials For Treatment Of Resistant Pathogens  
  2002.02.19 Anti-Infective Drug Trial Design  
  2001.11.7 Pfizer Zithromax Single-Day, Three-Day Dosing (azithromycin)
米国発売1992
1124 2001.10.16 Lilly Xigris Committee Review For Sepsis※敗血症
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果/Minutes】[有効性]Y=14,N=6,保留0  [適応を重症に制限するか?]Y=13,N=7,保留0  [検査でDICと判定されていないでの臨床試験をを追加するか?]Y=1,N=18,保留1  [Xigris服用患者への低用量ヘパリン使用の臨床試験を追加するか?]Y=20,N=0,保留0  [Xigrisの出血イベントに関連して、最適の用法用量研究を追加するか?]Y=0,N=20,保留0  [総合的に有効性と安全性において成人で承認すべきか?]Y=10,N=10,保留0  [小児では?]Y=0,N=16,保留4 
(Drotrecogin alfa (activated))
FDA承認=21-Nov-2001
  2001.04.26 Aventis Ketek Review telithromycin
  2001.04.24 Cerebral Palsy Drug Trial Design - Pediatric Subcmte.  
  2001.04.23 Hepatitis C Drug Development - Pediatric Subcmte.  
  2001.01.30 GlaxoSmithKline Augmentin ES Committee Review (Amoxicillin/
Clavulanate Potassium)
FDA承認=22-Jun-01
  2000.09.12 Rx Drug Therapy For Nursing Mothers  
  2000.09.12 Pediatric Oncologic Drug Development For Limited Patient Populati  
  2000.09.11 Placebo-Controlled Pediatric Trials  
1116-17 2000.07.28 Cipro For Anthrax Post-exposure Prophylaxis シプロ(ciprofloxacin)
 
1079 2000.03.24 Pharmacia Zyvox Review For Various Infections (linezolid)
FDA承認=18-Apr-2000
ML 開催日 議題 備考
     
1508 2015.10.23 (NDA) 207988, lesinurad oral tablets, submitted by Ardea Biosciences, Inc., for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor. 
※資料Briefing Information | Slides | 議事録/Transcripts | 【審議結果/Minutes】[有効性]Y=14,N=0,保留=0 [安全性]Y=7,N=6,保留=1 [承認すべきか]Y=10,N=4,保留=0
lesinurad
  2014.02.10-11 The committees will discuss data and analyses published in 2006 or later that are relevant to further understanding the relationship between non-steroidal anti-inflammatory drugs (NSAIDs) and cardiovascular thrombotic risk that is currently described in NSAID class labeling. 
※資料Briefing Information | Slides | 議事録/Transcripts10 - 議事録/Transcripts11 | 【審議結果/Minutes】 [naproxenは他のNSAIDSより血栓リスクが低いか?]Y=9,N=16,保留=0 [NSAIDSの提出データはCV血栓リスクの遅延に関するアドバイスを再考すべきものか?]Y=14,N=11,保留=0
NSAIDS
  2013.07.23 (sBLA) 125057, HUMIRA (adalimumab) injection, by AbbVie Inc. for the proposed indication of reducing signs and symptoms in adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation by elevated C-reactive protein (CRP) or magnetic resonance imaging (MRI), who have had an inadequate response to, or are intolerant to, a nonsteroidal anti-inflammatory drug. 
※資料Briefing Information | Slides | 議事録/Transcripts | 【審議結果/Minutes】 []Y=,N=,保留= 
adalimumab
1435 2013.07.23 (sBLA) 125160, CIMZIA (certolizumab) injection, by UCB, Inc., for the proposed indication of treatment of adult patients with active axial spondyloarthritis, including patients with ankylosing spondylitis. 
※資料Briefing Information | Slides | 議事録/Transcripts | 【審議結果/Minutes】 [採決無し]
certolizumab
1435 2013.07.22 discuss the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial spondyloarthritis and the implications of using these criteria for drug approval. 
※資料Briefing Information | Slides | 議事録/Transcripts | 【審議結果/Minutes】 [採決無し]
certolizumab
  2012.12.20 (NDA) 22151, rintatolimod injection (proposed trade name AMPLIGEN) submitted by Hemispherx Biopharma, Inc. for the treatment of patients with chronic fatigue syndrome. 
※資料Briefing Information | Slides | 議事録/Transcripts | 【審議結果/Minutes】 []Y=,N=,保留= 
rintatolimod
  2012.05.09 (NDA) 203214, tofacitinib tablets, Pfizer Inc., for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). 
※資料Briefing Information | Slides | 議事録/Transcripts | 【審議結果/Minutes】 []Y=,N=,保留= 
tofacitinib
  2012.05.08 supplemental biologics license application 125249, ARCALYST (rilonacept) injection, Regeneron Pharmaceuticals, Inc., for the following proposed indication: "ARCALYST (rilonacept) is an interleukin-1 blocker indicated for the prevention of gout flares during initiation of uric-acid lowering therapy in adult patients with gout. ARCALYST has not been studied for longer than 16 weeks in this clinical setting." 
※資料Briefing Information | Slides | 議事録/Transcripts | 【審議結果/Minutes】 []Y=,N=,保留= 
ARCALYST (rilonacept)
  2012.03.12 The committee will discuss the anti-nerve growth factor (anti-NGF) drug class that is currently under development and the safety issues possibly related to these drugs. These drugs are being developed for the treatment of a variety of chronic painful conditions including osteoarthritis, chronic lower back pain, diabetic peripheral neuropathy, post-herpetic neuralgia, chronic pancreatitis, endometriosis, interstitial cystitis, vertebral fracture, thermal injury, and cancer pain. The committee will be asked to determine whether reports of joint destruction represent a safety signal related to the anti-NGF class of drugs, and whether the risk benefit balance for these drugs favors continued development of the drugs as analgesics. 
※資料Briefing Information | Slides | 議事録/Transcripts | 【審議結果/Minutes】 []Y=,N=,保留= 
anti-NGF
1423 2011.06.21 (sBLA) 125319, ILARIS (canakinumab), Novartis Pharmaceuticals Corporation, for the following proposed indication: "ILARIS is indicated for the treatment of gouty arthritis attacks. ILARIS has also been shown to extend the time to the next attack and reduce the frequency of subsequent attacks." 
※資料Briefing Information | Slides | 議事録/Transcripts | 【審議結果/Minutes】 [gouty arthritis attacksの治療効果]Y=11,N=1,保留=0  [発作頻度の軽減]Y=8,N=4,保留=0  [安全性は十分か?]Y=0,N=12,保留=0  [有効性と安全性エビデンスは承認に十分か?]Y=1,N=11,保留=0  [発作頻度の軽減の有効性と安全性エビデンスは承認に十分か?]Y=0,N=12,保留=0
canakinumab
1366 2010.11.16 (BLA) 125370, belimumab, proposed trade name BENLYSTA, sponsored by Human Genome Sciences, for the proposed indication of reducing disease activity in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE). 
※資料Briefing Information | Slides | 議事録/Transcripts | 【審議結果/Minutes】[有効性]Yes=10,No=5,保留=0 [安全性]Yes=14,No=1,保留=0 [承認可否]Yes=13,No=2,保留=0
belimumab
  2010.08.20 (NDA) 22-531, sodium oxybate, 375 milligrams per milliliter (mg/ml) oral solution, sponsored by Jazz Pharmaceuticals, with a proposed indication for the treatment of fibromyalgia for patients 18 years of age and older. The safety and efficacy findings for sodium oxybate in the fibromyalgia population and the proposed Risk Evaluation and Mitigation Strategy (REMS) for this product will be discussed. 
※資料Briefing Information | Slides | 議事録/Transcripts | 【審議結果/Minutes】[承認可否]Yes=2,No=20,保留=0
sodium oxybate
  2010.05.12 (NDA) 22-478, naproxcinod 375 milligram capsule, sponsored by NicOx S.A., a non-steroidal anti-inflammatory drug (NSAID) product indicated for the treatment of the signs and symptoms of osteoarthritis. 
※資料Briefing Information | Slides | 議事録/Transcripts | 【審議結果/Minutes】>[承認可否]Yes=1,No=16,保留=1
naproxcinod
  2009.09.16 (BLA) 125338, clostridial collagenase, Auxilium Pharmaceuticals, Inc., デュピュイトラン病(Dupuytren's disease)治療薬
※資料Briefing Information | Slides | 議事録/Transcripts | 【審議結果/Minutes】[承認可否]Yes=12,No=0,保留=0
clostridial collagenase
1357 2009.06.16 (BLA) 125293, KRYSTEXXA (pegloticase), Savient Pharmaceuticals, Inc.再発性慢性痛風
※資料Briefing Information | 【審議結果/Minutes】[承認可否]Yes=14,No=1,保留=0
KRYSTEXXA (pegloticase)
1312 2008.11.24 (NDA) 21-856, ULORIC (febuxostat), Takeda Pharmaceuticals North America, Inc., 高尿酸血症治療剤
※資料Briefing Information | Slides | Transcript: Part1 - Part2 - Part3 | 【審議結果/Minutes】[慢性痛風治療薬として承認可否]Yes=12,No=0,保留=1
ULORIC (febuxostat)
1340 2008.07.29 (BLA) 125276, ACTEMRA (tocilizumab),Hoffman-La Roche, Inc., リウマチ
※資料Briefing Information | Slides | 【審議結果/Minutes】[承認可否]Yes=10,No=1,保留=0
ACTEMRA (tocilizumab)
  2007.4.12 ARCOXIA (etoricoxib), Merck & Co., Inc.,変形性関節症  
※資料Briefing Information | 【審議結果/Minutes】
ARCOXIA (etoricoxib)
  2006.11.29 CELEBREX (celecoxib), Pfizer, Incの若年性リウマチ
※資料Briefing Information | 【審議結果/Summary Minutes】 1)承認可否16-0 2)安全性データは十分か?Y=7/N=8/保留=1 3)celecoxibのJRA適応でのrisk/benefit比は十分か?15-1
CELEBREX (celecoxib)
1229 2005.09.06 Bristol-Myers Squibb Orencia (Abatacept) For Rheumatoid Arthritis
※[Brief Information]
※[審議結果]全員一致で推奨。FDAはBriefingで重症感染リスクの増加とa potential risk of malignancy with the T-cell costimulation modulatorについての関心を表明していた。Committee consultant David Felson (Boston University)はabataceptが「他のTNF inhibitors同様の安全性プロファイルを持つ」とした。市販TNF阻害剤は、Abbott’s Humira, Amgen/Wyeth’s Enbrel and J&J’s Remicade). 委員は、感染、malignancy riskおよびI型糖尿病のような自己免疫疾患は、最も重大な安全性課題であるとした。 因みにOrenciaのBristol社pharmacovigilance program はOrencia使用群5000例と他剤使用群15,000例の比較Cohortデータを含む。
Orencia(abatacept)
  2005.02.16 Merck Vioxx/COX-2 Inhibitor Safety Review - Day 1
※Arthritis Drugs and Drug Safety & Risk Management Committees合同
※COX-2阻害剤の消化器安全性および心管系副作用を含めたbenefit-risk profileを検討する。 これはVioxxの市場回収に端を発し、今回の会議でPfizer社のCelebrex (celecoxib), Bextra (valdecoxib)およびPfizerの治験薬prodrug parecoxibの今後が決定される。 FDAは、2004.12.23にCOX-2阻害剤に関する警告を発令、"The caution leaves open the possibility for patients to use Pfizer’s Celebrex and Bextra as first-line therapies"
※[審議]Pfizer社は心管系副作用はVioxxに特有のものでCelebrex , Bextra などCOX-2阻害剤全体のものではないとの主張を展開した。 これに対し委員Garret FitzGerald (University of Pennsylvania)は、両剤とも現在策定中の新しいStandardで再評価すべきで、使用制限を厳しくし、特に60才以上には配慮すべきとした。
 
  2005.02.17 Merck Vioxx/COX-2 Inhibitor Safety Review - Day 2
※[審議]心管系副作用はVioxxに特有のものではなく、COX-2阻害剤全体のものと諮問委は結論。しかし用量や成分間の差はある。
 
  2005.02.18 Merck Vioxx/COX-2 Inhibitor Safety Review - Day 3
※[審議結果]1)Vioxx (rofecoxib) のrisk-benefit総体として、販売を支持するか? 17:15で支持派が優勢。 2)Bextra (valdecoxib)は販売を継続すべきか? 17:13:保留2 3)Celebrex (celecoxib) は販売を継続すべきか? 31:1
※3剤とも黒枠警告表示は義務づけられる。 メルク社はAPPROVe試験結果によりVioxx販売中止を決めたが、再販売を検討しており、その可能性が出てきた。しかしVioxxは2nd/3rd-lineでの使用となり、用量も従来の25mg/50mgから12.5mgに制限される。
 
  2004.06.02 Cardiome's Oxyprim: Chronic Gout Trial Design, Endpoints
※アロプリノール代謝物でアロプリノール無効のhyperuricemiaへの認可を審議。 2003.11.23申請。 現在、痛風薬として開発中なのは他にTAP/Teijin's xanthine oxidase inhibitor febuxostat (TMX-67) and Savient's Puricase (rPEG-uricase). febuxostatは現在P3段階で2004年に痛風の適応で申請予定でTAPが帝人からライセンスを受けたもの。 Puricaseは、現在P1。遺伝子組み替えPEG-uricase conjugateで過剰な尿酸を排泄する。
※[審議結果]oxypurinol他の慢性痛風薬はsurrogate endpointsに基づき迅速承認を受けることができたと結論。
Oxyprim
(oxypurinol)
  2004.06.03 Merck's Arcoxia: Acute Gout Trial Design, Endpoints
※メルク社は2002.3 Arcoxia申請を取り下げ、その後ankylosing spondylitis[強直性脊椎炎]の追加データを揃えた。 今回他のCOX-2阻害剤と異なり、急性の痛風性関節炎の適応を申請(2003.12)している。7種の適応で申請。
※[審議結果]急性痛風についてArcoxiaはindometacinと比較試験されたが概ね適切。
Arcoxia
(etoricoxib)
  2003.9.29
FDA Lupus Draft Guidance - Day 1[ループス=狼瘡]
※systemic lupus erythematosus[SLE=全身性エリテマトーデス,全身性紅斑性狼瘡]等を含む
※La Jolla Pharmaceuticalsが2003年末までにlupus agent Riquent (LJP 394)のNDA申請を予定
 
  2003.9.30
FDA Lupus Draft Guidance - Day 2  
  2003.6.23 Fibromyalgia[線維筋痛症;旧fibrositis] Clinical Trial Design
※筋肉痛・疲労障害の適応症で認可された薬剤はないが、現在慢性痛症状が抗うつ剤、NSAIDS,GABA作動薬、Na-Ca拮抗剤等で治療されている。 fibromyalgiaについては数種の薬剤のP2臨床試験が行われている。
※臨床試験は最低6か月以上、などと答申
※June 23, 2003 Transcript
pregabalin(Pfizer)P3
milnacipran[Cypress Bioscience]P2
Novaban(tropisetron)[Novartis]P2/3
  2003.6.24 Wyeth/Amgen Enbrel For Ankylosing Spondylitis(強直性脊椎炎:慢性関節リウマチに似た脊椎の関節炎)
※関連薬剤もRemicade (infliximab)はP3,Humira (adalimumab)も2〜3か月以内に臨床試験開始
※諮問委は、追加適応を付帯条件なしに了承
etanercept
1040 2003.03.05 Aventis Arava Physical Function Claim
※関節リウマチの物理的機能改善効果に関してと安全性の評価更新
Aravaはリスク以上のメリットがあり、リスクも他のRA用薬剤以上ではなく、肝臓毒性については現行の添付文書でも警告されているので、改訂の必要はないとの結論。しかし、死亡例はないものの市販後調査で急性肝不全が16例報告されもうち2例はAravaとの関連が疑われている
※FDA Brief Information
(Leflunomide)
[Aventis/
Quintiles]
FDA承認
14-Sep-1998
1153 2003.03.04 TNF Inhibitor Safety Review
※前回2001.8.17実施のレビューに続き免疫異常(lymphoproliferative disorders=リンパ球増殖性異常)のリスクが焦点
Medwatch 99/5-2000/12でetanercept 18例,infliximab 8例;その大半81%が非ホジキン性リンパ腫。
2001/11-2002/9のリンパ腫68例が検討された。
→3品目のラベル改訂
※FDA Brief Information
etanercept
(Enbrel[Amgen])
infliximab
(Remicade[Centocor])
Humira[Abbott,FDA承認
31-Dec-2002]
  2002.07.30 Pain Indication Trial Design - Day 2  
  2002.07.29 Pain Indication Trial Design - Day 1  
  2001.08.17 Immunex Enbrel and J&J Remicade Safety Updates  
1124 2001.08.16 Amgen Kineret For Rheumatoid Arthritis (Anakinra)
  2001.04.19 Genelabs/Watson Aslera For Treatment Of Lupus  
1056 2001.02.8 Merck Vioxx GI Toxicity Labeling (rofecoxib)
1045 2001.02.7 Pharmacia Celebrex GI Toxicity Labeling (celecoxib)
1040
1047
2000.07.12 Centocor Remicade Committee Review Infliximab
1040 2000.04.11 Immunex Enbrel Committee Review Etanercept
ML 開催日 議題 備考
     
  2016.
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留=  
 
  2016.06.20 the Committee members will participate in the meeting via teleconference. In open session, the Committee will discuss the research programs in the Laboratory of Plasma Derivatives in the Division of Hematology Research and Review, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA.
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留=  
 
  2015.05.13 the Committee will meet in open session to discuss strategies for implementation of serological and nucleic acid testing for Babesia microtiin blood donors. In the afternoon, the committee will hear update presentations on the following topics: 1) FDA considerations for Hemoglobin S Testing in blood donors; and 2) FDA considerations for a revised blood donor deferral policy for men who have sex with men.
※資料Topic I: Issue Summary - Strategies for Implementation of Antibody and Nucleic Acid-based Testing for Babesia microti in Blood Donors | 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留=  
 
  2014.12.03 The Committee will be presented with an update on the November 13, 2014, meeting of the Advisory Committee on Blood and Tissue Safety and Availability where the MSM blood donor deferral policy will be discussed.
※資料FDA Executive Summary | FDA Executive Summary- Updated | 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留=  
 
  2014.12.02 the Committee will meet in open session to hear scientific data related to reconsideration of the current blood donor deferral policy for men who have had sex with another man (MSM) even one time since 1977.
※資料Issue Summary | 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留=  
 
1476 2014.07.31 The committee will meet in open session to discuss Baxter Healthcare Corporation’s biologics license application for HyQvia, Immune Globulin Infusion 10 percent (human) combined with Recombinant Human Hyaluronidase for the treatment of patients with primary immune deficiency disorders. In the afternoon, the Committee will meet in open session to discuss reentry of blood donors deferred on the basis of Chagas disease test results.
※資料Briefing Information | 議事要旨Minutes | 議事録Transcript | 【審議結果】[ベネフィットがリスクを上回るか?]Y=15,N=1,保留=0 [神経系や消化器官系炎症を持つ妊婦や男性小児への使用を制限すべきか?]Y=5,N=9,保留=2 [リスクコミュニケーション戦略として医師がHyQvia使用を知らせる決定をすべきか?]Y=16,N=0,保留=0 [抗PH20抗体の増加をモニタリングすべきか?]Y=6,N=10,保留=0
HyQvia, Immune Globulin Infusion
  2014.03.19 The committee will meet in open session to hear presentations on the research programs of the Laboratory Hemostasis, Division of Hematology, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA.
※資料Briefing Information | 議事録Transcript | 【審議結果】[]Y=,N=,保留=  
 
  2014.03.18 The committee will meet in open session to discuss the evaluation of the safety and effectiveness of the Immucor PreciseType™ HEA Molecular BeadChip Assay, manufactured by BioArray Solutions Limited. In the afternoon, the committee will hear update presentations on the following topics: (1) Report from the Presidential Commission for the Study of Bioethical Issues on the ethical implications of incidental findings in clinical, research, and direct-to-consumer contexts; (2) summary of the January 28-29, 2014, FDA public workshop on immune globulin-associated hemolysis; and (3) a summary of the December 4-5, 2013, HHS Advisory Committee on Blood and Tissue Safety and Availability.
※資料Briefing Information | 議事録Transcript | 【審議結果】[]Y=,N=,保留=  
Immucor PreciseType™ HEA Molecular BeadChip Assay
  2013.11.01 The Committee will meet in open session to discuss MP Biomedicals' biologic license application for the MP Diagnostics HTLV Blot 2.4, a Western Blot intended for use as a confirmatory test for blood donors. In the afternoon, the committee will hear update presentations on the following topics: (1) The April 2013 FDA public workshop on multiplex detection of transfusion transmissible agents and blood cell antigens in blood donations and (2) FDA safety communications on new boxed warnings for immune globulin products and hydroxyethyl starch solutions. Following the update presentations, the committee will meet in open session to hear presentations on the research programs of the Laboratory of Biochemistry and Vascular Biology, Division of Hematology, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA.
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果】[]Y=,N=,保留=  
MP Diagnostics HTLV Blot
  2013.08.02 The Committee will meet in open session to hear updates on the research programs of the Laboratory of Molecular Virology, Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA.
※資料 | 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留=  
 
1443 2013.02.12 The Committee will meet in open session to discuss Cangene’s biologics license application for Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)-(Equine) seeking licensure under FDA’s authority to approve a product based on evidence of safety in humans and effectiveness from studies in animals when human efficacy studies are not ethical or feasible.
※資料Briefing Information | 議事要旨Minutes | 議事録Transcript | 【審議結果】[有効性は十分?]Y=14,N=0,保留=0 [安全性は十分?]Y=14,N=0,保留=0 [動物実験とシミュレーションモデルによる人体用量設定は十分か?成人]Y=14,N=0,保留=0 [動物実験とシミュレーションモデルによる人体用量設定は十分か?小児]Y=12,N=1,保留=1
Botulism Antitoxin Heptavalent
  2012.12.05 The Committee will meet in open session to discuss performance data considerations for infectious disease assays used to screen organ donors.
※資料Briefing Information | 議事録Transcript | 【審議結果】[]Y=,N=,保留=  
 
  2012.12.04 The Committee will meet in open session to discuss labeling of Red Blood Cells with historical antigen typing results
※資料Briefing Information | 議事録Transcript | 【審議結果】[]Y=,N=,保留=  
 
  2012.09.21 The committee will discuss considerations for strategies to further reduce the risk of bacterial contamination in Platelets.
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留=  
 
  2012.09.20 The committee will discuss hepatitis E virus and blood transfusion safety. In the afternoon, the committee will discuss Octapharma’s biologics license application for Pooled Plasma (Human, Solvent/Detergent Treated).
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留=  
Pooled Plasma (Human, Solvent/Detergent Treated)
  2012.06.12 The Committee will meet, by teleconference, in open session, to hear updates on the research programs of the Laboratory of Emerging Pathogens and the Laboratory of Bacterial and Transmissible Spongiform Encephalopathy Agents, Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA. From approximately 3:45 p.m. to 4:30 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The committee will discuss the site visit report of the intramural research programs and make recommendations regarding personnel staffing decisions.
※資料 | 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留=  
 
  2012.05.16 The committee will discuss the evaluation of possible new plasma products frozen following in-process storage at room temperature for up to 24 hours, namely plasma for transfusion prepared from Whole Blood held at room temperature for up to 24 hours prior to separation and freezing, or from apheresis plasma held at room temperature for up to 24 hours before freezing. In the afternoon, the committee will hear update presentations on the following topics: HHS activities related to the evaluation of the donor deferral policy for men who have had sex with other men; a summary of the November 8-9, 2011, public workshop on hemoglobin standards and maintaining an adequate blood supply; and a summary of the November 29, 2011, public workshop on data and data needs to advance risk assessment for emerging infectious diseases for blood and blood products.
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果】[]Y=,N=,保留=  
 
  2012.05.15 The committee will discuss as a device panel the evaluation of the safety and effectiveness of the OraQuick In-Home HIV Test.
※資料Briefing Information | 議事録Transcript | 【審議結果】[]Y=,N=,保留=  
OraQuick In-Home HIV Test
  2011.08.03 The committee will discuss measures to preserve the blood supply during a severe emergency. In the afternoon, the committee will hear the following updates: Summary of the June 7-8, 2011, Health and Human Services Advisory Committee on Blood Safety and Availability meeting; summary of the May 17-18, 2011, public workshop on risk mitigation strategies to address procoagulant activity in immune globulin products; and summary of the August 1-2, 2011, Transmissible Spongiform Encephalopathies Advisory Committee meeting.
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果】[]Y=,N=,保留=  
 
  2011.08.02 the committee will discuss a study on the incidence of Trypanosoma cruzi infection in blood donors and its implications for selective testing of blood donors.
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果】[]Y=,N=,保留=  
 
  2011.04.29 in the morning, the committee will discuss blood donor written statement of understanding. In the afternoon, the Committee will hear an update from the Department of Health and Human Services’ Office of the Assistant Secretary for Health and an update on public workshops FDA is considering sponsoring on thrombotic adverse events associated with Immune

Globulin Intravenous, toxicities of Hydroxyethyl Starch Solutions, and measurement of hemoglobin in blood donors.
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果】[]Y=,N=,保留=  

 
  2011.04.28 In the morning, the committee will discuss testing donations of Source Plasma for hepatitis B virus infection by nucleic acid testing. In the afternoon, the committee will discuss current considerations on use of plasma obtained from Whole Blood donors for further manufacturing
※資料Briefing Information | Slides | 議事録Transcript | 【審議結果】[]Y=,N=,保留=  
 
  2010.12.15 In the morning, the committee will hear updates on the following topics: (1) November 4 and 5, 2010, meeting of the Health and Human Services Advisory Committee on Blood Safety and Availability and (2) December 9 and 10, 2010, FDA workshop entitled “Product Development Program for Interventions in Patients With Severe Bleeding Due to Trauma and Other Causes,” and (3) Research programs in the Laboratories of Hemostasis and Plasma Derivatives, Division of Hematology, Office of Blood Research and Review, Center for Biologics Evaluation and Research.   
  2010.12.14 In the morning, the committee will discuss the risk of dengue virus infection in blood donors. In the afternoon, the committee will discuss murine leukemia virus-related human retroviruses and blood safety.   
  2010.07.27 blood donor hemoglobin/hematocrit qualifications standards, iron status and interdonation interval 
※議事録Transcript | 【審議結果】[]Y=,N=,保留= 
 
  2010.07.26 On July 26, in the morning session, the Committee will hear updates on the following topics: June 10-11, 2010 meeting of the HHS Advisory Committee on Blood Safety and Availability; December 14-15, 2009 FDA workshop on emerging arboviruses; May 11-12, 2010 FDA workshop on emerging infectious diseases; and the Q fever epidemic in the Netherlands. The Committee will also hear informational presentations on Xenotropic Murine Leukemia Virus-Related Virus (XMRV). In the afternoon session, the Committee will discuss issues related to the risk of Babesia infection by blood transfusions and the status of laboratory tests. 
※資料Topic 1 Final Babesia Issue Summary | 資料Topic 2 Hemoglobin and Iron Issue Summary | 資料Xenotropic Murine Leukemia Virus-Related Virus (XMRV) - Informational Presentation | 議事録Transcript | 【審議結果】[]Y=,N=,保留= 
 
  2010.04.12 open session to hear updates on the research programs of the Laboratory of Cellular Hematology and the Laboratory of Biochemistry and Vascular Biology, Division of Hematology, Office of Blood Research and Review, CBER, FDA 
※開催中止
 
  2009.11.16 Topic I: Blood Donor Deferral for Malaria Risk Associated with Travel to Mexico
※資料Summary Topic1 | 議事録Transcript | 【審議結果】
 
  2009.11.16 Topic 2: Study Designs (Phases 3 and 4) for Product Development of Human Platelets Using the Cerus INTERCEPT Blood System for Pathogen Inactivation 
※資料P3試験データ | Summary Topic2 | 議事録Transcript | 【審議結果】
 
  2009.11.17 Topic 3: Blood Pressure and Pulse as Blood Donor Eligibility Criteria 
※資料Summary Topic3 | 議事録Transcript | 【審議結果】
 
  2009.11.17 Topic 4: Public Health Need and Performance Characteristics for Over-the-Counter Home-Use HIV Test Kits 
※資料Summary Topic4 | 議事録Transcript | 【審議結果】
 
  2009.07.20 new coral snake antivenoms 
※資料References | Summary Topic1 | 議事録Transcript | 【審議結果】
 
  2009.07.20 Alpha-1 Proteinase Inhibitor (Human) augmentation therapy in Alpha-1 antitrypsin deficiency. Alpha-1 antitrypsin deficiency is a genetic condition associated with decreased circulating levels of alpha-1 antitrypsin that significantly increases the risk of serious lung disease (i.e. emphysema) in adults 
※資料References | Summary Topic2 | 議事録Transcript | 【審議結果】
 
  2009.07.21 updates on the following topics: April 30-May 1, 2009 meeting of the DHHS Advisory Committee on Blood Safety and Availability1; June 12, 2009 meeting of the FDA Transmissible Spongiform Encephalopathies Advisory Committee2; and an overview of the epidemiology and virology of the 2009 A/H1N1 influenza virus and its impact on the U.S blood system. The Committee will also hear informational presentations on recent public and private hemovigilance efforts, including the pilot hemovigilance module in the National Healthcare Safety Network. 
※資料| 議事録Transcript
 
  2009.04.01-02 blood donor screening, and testing donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps) for hepatitis B virus infection by nucleic acid testing 
※資料Briefing Information | 議事録Transcript1 | Transcript2 | 【審議結果】
 
  2009.01.09 Riastap[CSL Behring] for plasma-derived fibrinogen concentrate for treatment of bleeding in congenital fibrinogen deficiency 
※資料Briefing Information | 議事録Transcript | 【審議結果】
Riastap
1323 2009.01.09 Atryn[GTC Biotherapeutics] for recombinant Antithrombin III derived from genetically engineered goats for treatment of patients with hereditary Antithrombin III deficiency to prevent thrombosis during high risk situations like surgery and obstetrical procedures. 周術期および周産期の血栓塞栓性イベント予防に対する有効性と安全性を審議
※資料Briefing Information | 議事録Transcript | 【審議結果】[1)安全性プロファイル可否]Yes=18,No=0,保留=1 [2)非妊娠手術患者と周産期の妊婦での血栓塞栓性イベント予防に対するAtrynの有効性]Yes=16,No=1,保留=2 [3)市販後調査で反復投与後の安全性と免疫原性を含めるべきか?]Yes=19,No=0,保留=0
Atryn
  2008.09.11 (1) April 29 to 30, 2008, workshop on hemoglobin based oxygen carriers; (2) July 10 to 11, 2008, blood establishment computer software conference; (3) the development of an automated Biologics License Application submission system; and (4) Draft Guidance for Industry: Re-qualification Method for Re-entry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc). 
※資料Briefing Information | 議事要旨Minutes
 
  2008.09.10 strategies to enhance bacterial safety of 7 day platelets for transfusion 
※資料Briefing Information | 議事要旨Minutes
 
1345 2008.05.02 Lev Pharmaceutical's plasma-derived C1 esterase inhibitor (CINRYZE) 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript - [2] - [3] | 【審議結果】[]Y=,N=,保留= 
CINRYZE
  2008.05.01 (1) Summaries of August 22-23, 2007, and January 9-10, 2008, meetings of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability; (2) 2007 West Nile Virus Epidemiology and the use of nucleic acid tests to reduce the risk of transmission of West Nile Virus in Whole Blood and blood components for transfusion and Human Cells, Tissues, and Cellular and Tissue-based products (HCT/Ps); (3) implementation of blood donor screening for infection with Trypanosoma cruzi and the use of serological tests to reduce the risk of transmission of T. cruzi infection in Whole Blood and blood components for transfusion and HCT/Ps; (4) FDA's proposal to lower the minimum recommended lot release titer for measles antibodies in Immune Globulin Intravenous (Human) and Immune Globulin Subcutaneous (Human); (5) Gambro/Fenwal Post Approval Surveillance Study of Platelet Outcomes, Release Tested (PASSPORT) Post Marketing Study--7 Day Platelets; (6) Experience with 7 Day Platelets Versus 5 Day Platelets; and (7) FDA Perspective on the PASSPORT Study. These updates will be followed by informational presentations on FDA's Center for Biologics Evaluation and Research Safety Teams related to blood and tissue. In the afternoon, the committee will discuss the Biomedical Excellence for Safer Transfusion Committee Report on red blood cell recovery standards. 
※資料Briefing Information | 議事要旨Minutes
 
  2006.12.14 HBOC-210 (Polymerized Bovine Hemoglobin-B):外傷および出血性ショック治療剤  
※資料Briefing Information | 議事要旨Minutes
 
  2006.07.13 Nabi Biopharmaceuticals' Hepatitis B IGIV for Prevention of Recurrent HBV Disease after Orthotopic Liver Transplantation  
※資料Briefing Information | 議事要旨Minutes
 
  2006.03.10 Proposed Studies For Approval Of Home HIV Test Kits; CBER Research Programs Summaries  
  2006.03.09 Blood Donor Screening For West Nile Virus; Draft Guidance On Automated Platelet Collection Methods  
  2005.11.04 Alpha-1 Proteinase Inhibitor Products; Adverse Events From Interference With Glucose Monitoring After Infusion With Maltose-Containing IVIG
現在米国で販売されるα1-プロテイナーゼ阻害剤はProlastin, Aralast, and Zemaira。 これら製品は承認時の初期構造に修飾を加えており、今回有効性と安全性の見直しを行うもの。 承認時のsurrogate endpointsは、serum and calculated epithelial lining fluid (ELF) levels of a1-PI and anti-neutrophil elastase inhibitory capacity (functional inhibitory activity)。 ZLB Behring and Baxterは、臨床的に有意なエンドポイント(CTによる肺の悪化と肺の密度の頻度とseverityを含む) での長期有効性評価試験を実施することに同意している。 加えて長期使用の安全性モニタリングプログラムを二つ(AlphaNet and the Coram study)実施。※[Brief Information]【審議結果】
 
  2005.11.03 OTC Home-Use HIV Test Kits; Donor Deferral; Nucleic Acid Testing; West Nile Virus  
1233 2005.09.29 Novartis Exjade For Iron Overload; CBER Hemostasis, Plasma Derivatives Labs Research Programs
輸血による慢性鉄過剰症の適応についてレビューする。 本剤は市販されている鉄キレート剤Desferal (deferoxamine)の代替薬として優先審査の対象となりユーザーフィーによる審査を受けてきた。 Novartis社の申請は1000例のpivotal研究に基づくものだが、Desferalに劣っては以内という程度の成績であったため、有効性のエビデンスには不十分とされた。 しかし同社の主張では、それは低用量(5 and 10 mg/kg)が原因で、高用量Exjade (20 and 30 mg/kg)では顕著な効果を示している。 因みに、経口鉄キレート剤がGenzymeでも開発しておりP2段階。※[Brief Information]【審議結果】輸血時のhemosiderosisというより広範囲の適応で承認すべきであるとの勧告。 βサラセミア(β-thalassemia;地中海貧血症)成人患者の試験結果から、諮問委全員が輸血時hemosiderosisに伴う貧血や血液異常にも適用されるとした。 また委員数人が鎌状赤血球(Sickle cell disease)、骨髄異形成症候群(Myelodysplastic syndrome)や他のhemotrophic disordersへの追加試験をすべきだとした。 臨床効果の問題にもかかわらず諮問委は承認に投票。 小児適応に関しては、5人が2才以上okとしたのに対し、8名が6才以上とした。
Exjade (deferasirox)
  2005.07.22 CBER Blood Research Programs Review  
  2005.07.21 Varicella Zoster Immune Globulin Trial Design, Alternatives; Hepatitis B Positive Blood Donor And Unit Management; Dextran Pre-Treatment
現在アシクロビルがvaricella zoster(chickenpox)感染治療の適応が認可されている。今回VZIGがアシクロビルの代替として重症VZの予防効果があるかという審議。 公表データに基づくFDA発表では IGIV and IG はVZIGに比べて低レベルと結論。 VZIGは1981年に初認可。 Merck社のVarivax(live attenuated varicella zoster vaccine)は12ヵ月以上の小児に使用されるが、VZIGは複合感染のハイリスク成人に推奨される。※[Brief Information]【審議結果】
VZIG
  2005.03.18 Abbreviated Uniform Donor History Study Design; Rapid Freezing of Plasma For Transfusion  
  2005.03.17 West Nile Virus Guidance, Albumin Safety, Critical Path, Other Blood Topics
※Briefing Information ">会議記録 | 資料Briefing Information | 議事要旨Minutes
 
  2004.10.21 Variant CJD Transmission; HIV/HCV Testing; Simian Foamy Virus  
  2004.10.22 Blood Donor Deferral For West Nile Virus; Plasma Donor Weight Monitoring  
  2004.07.23 West Nile Virus; Hepatitis B Nucleic Acid Testing  
  2004.07.22 Platelet Bacterial Contamination Monitoring; Irradiated Blood Dating  
  2004.03.18 Hepatitis B Immune Globulin For Re-Infection Prevention In Liver Transplant Patients; Other Topics
※B型肝炎再感染およびB型肝炎ウイルス陽性患者への肝臓移植に随伴する肝臓疾患を防止するため、B型肝炎免疫グロブリンの臨床試験について審議する。
※Nabi-HB(HBV-IG)[Nabi Pharmaceuticals]はB型肝炎ウイルス陽性患者への肝臓移植での再感染を予防する薬剤として2002.11.26にFDA申請、2003.5末にFDAより "complete response" letterを受領し、その後要求された追加データを提出してきたもの。 尚Nabi-HBは既に急性暴露に伴うB型肝炎ウイルス予防の適応で承認済み。
Nabi-HB[HBV-IG]
  2004.03.19 Blood Platelet Apheresis Quality Control; Reports on CBER Labs(アフェレーシス=必要な細胞または液性成分を除去したのちに,再び患者の血液を患者自身に輸注すること)
※FDAはGainesville, Fla.-based Life Community Blood Centers の二つに血小板製剤の規格不適合に関して警告状を送付した。 またCBERの研究機関Lab of Hepatitis and Emerging Bacterial Agents and the Lab of Bacterial, Parasitic and Unconventional Agentsの研究レビューを行う。
 
  2003.12.11 West Nile Virus Testing Update, Plans For 2004
※CDCによると2003.11.12時点で米国のWNV罹患8,393例うち死亡184例。 検査薬についてはCapture WNV IgM ELISA[PanBio] がflavivirus臨床検査薬として最初の2003.7.8承認。 次いで2003.10.22承認のIgG/IgM ELISA kit[Focus Technologies]。 臨床試験中がTaqScreen WNV[Roche]及びGen-Probe社のtranscription-mediated amplification screening test
 
  2003.12.12 Summary Of Factor VIII Inhibitor Workshop; MDUFMA Discussion  
  2003.9.18 Supplemental Testing For HIV-1 And Hepatitis C; Other Blood Safety Topics  
  2003.6.19 SARS, West Nile Virus Presentations  
  2003.6.20 Vaccinia Immunoglobulin Indications; Recovered Plasma
※天然痘VIG
 
  2003.3.14 Pooled Platelet Dating Period Extension Will Be Subject Of Blood Products Meeting
※血小板の保存期限
 
  2003.03.13 West Nile Virus Nucleic Acid Testing
※FDAは血液製剤のドナー適合性と西ナイルウィルスに対する安全性最終ガイダンスを2002.10に発行
 
  2002.12.12 Parvovirus B19 Nucleic Acid Testing  
  2002.06.14 Hetastarch And Bleeding Labeling Warning  
  2002.06.13 Standards for Recovered Plasma  
  2002.03.15 Platelet Dating Period And Tissue Safety  
  2002.03.14 Blood Donor Exposure To Tattoos; Nucleic Acid Testing  
  2002.01.17 TSE/Blood Products Joint Cmte. Meeting  
  2001.12.14 Blood Safety and Transmissible Diseases  
  2001.12.13 Blood Safety And Transmissible Diseases  
  2001.06.14 Deferred Blood Donor Re-entry After HIV Testing  
  2000.06.16 Hepatits C And Hepatitis B Testing  
  2000.06.15 HIV, Hepatitis A Tests Development  
  2000.03.17 Red Blood Cell Substitutes Discussion - Day 2  
  2000.03.16 Red Blood Cell Substitutes Discussion - Day 1  
ML 開催日 議題 備考
     
   
※資料Briefing Information | slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
 
1480 2015.04.15 (NDA) 204958, cangrelor injection, submitted by The Medicines Company, for the proposed indication of reduction of thrombotic cardiovascular events in patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI)--(PCI refers to the opening of narrowed blood vessels supplying the heart muscle by a balloon inserted through an artery puncture with or without a stent) who have not received an oral P2Y12 inhibitor prior to the PCI procedure and in whom oral therapy with P2Y12 inhibitors is not feasible or desirable (P2Y12 is a protein involved in blood clotting. Inhibiting this protein is a key mechanism of action of cangrelor). 
※資料Briefing Information | slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[承認すべきか?] Y=9,N=2,保留=1
cangrelor
1465 2014.10.30 (NDA) 206316, edoxaban tablets, submitted by Daiichi Sankyo, Inc., for the prevention of stroke and systemic embolism (blood clots other than in the head) in patients with nonvalvular atrial fibrillation (A Fib; abnormally rapid and chaotic contractions of the atria, the upper chambers of the heart). 
※資料Briefing Information | slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
edoxaban
  2014.09.10 The committee will be asked to discuss the potential clinical utility of fixed-combination prescription drugs composed of an anti-hypertensive drug, aspirin, and a statin administered to reduce the risk of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke in patients with a history of cardiovascular disease. The committee will be asked to discuss the patient population that could benefit from such a product, whether that population would be likely to take such a drug long term, and how this could be assured. The committee will also be asked to consider the pros and cons of a treatment that would not be titrated and in a setting where monitoring might not be rigorous. 
※資料Briefing Information | slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
 
  2014.09.09 (NDA) 206302, nebivolol/valsartan fixed-dose combination tablets (5/80 milligrams (mg), 5/160 mg, 10/160 mg, 10/320 mg and 20/320 mg), submitted by Forrest Laboratories, Inc., for the proposed indication of the treatment of hypertension. 
※資料Briefing Information | slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
nebivolol/valsartan
  2014.03.27 125468, serelaxin injection, submitted by Novartis, as a treatment to improve the symptoms of acute heart failure through reduction of the rate of worsening of heart failure. 
※資料Briefing Information | slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
serelaxin
1480 2014.02.12 (NDA) 204958, cangrelor injection, submitted by The Medicines Company, for the proposed indication of reduction of thrombotic cardiovascular events including stent thrombosis (events related to blood clots in a stent, a device inserted to keep the artery open) in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI). PCI refers to the opening of narrowed blood vessels supplying the heart muscle by a balloon inserted through an artery puncture with or without a stent. The applicant is also proposing that cangrelor be indicated to maintain P2Y12 inhibition in patients with acute coronary syndromes or patients with stents who are at increased risk for thrombotic events (such as stent thrombosis) when oral P2Y12 therapy is interrupted due to surgery. P2Y12 is a protein involved in blood clotting; inhibiting this protein is a key mechanism of action of cangrelor.  
※資料Briefing Information | slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[血栓性心管系イベントの低減で承認すべきか?] Y=2,N=7,保留=0 [経口P2Y12療法が外科手術のため中断された場合、ステント血栓症リスクのあるステント留置患者のために承認すべきか?] Y=0,N=9,保留=0
cangrelor
  2014.01.16 (sNDA) 202439/S-002, rivaroxaban, trade name XARELTO 2.5 milligram tablets, submitted by Janssen Pharmaceuticals, Inc., for the proposed indication to reduce the risk of thrombotic cardiovascular events in patients in the first 90 days after suffering acute coronary syndrome [ST elevation myocardial infarction, non-ST elevation myocardial infarction, or unstable angina].  
※資料Briefing Information | slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
rivaroxaban
1451 2014.01.15 (NDA) 204886, vorapaxar sulfate, proposed trade name ZONTIVITY, 2.5 milligram tablets, submitted by Merck Sharp & Dohme Corp., Inc., for the proposed indication of reduction of atherothrombotic events in patients with a history of myocardial infarction (MI). The applicant also proposes that ZONTIVITY has been shown to reduce the rate of a combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization 
※資料Briefing Information | slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[承認すべきか?] Y=10,N=1,保留=0
vorapaxar
1471 2014.01.14 (NDA) 203202, NORTHERA (droxidopa capsules), submitted by Chelsea Therapeutics, Inc., for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure (Parkinson's disease, multiple system atrophy, or pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy.  
※資料Briefing Information | slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[承認すべきか?] Y=16,N=1,保留=0
NORTHERA (droxidopa capsules)
1437 2013.08.06 (NDA) 204819, proposed trade name ADEMPAS (riociguat coated tablet), submitted by Bayer HealthCare Pharmaceuticals Inc., for the treatment of 1) chronic thromboembolic pulmonary hypertension (CTEPH) World Health Organization (WHO) Group 4 to improve exercise capacity and WHO functional class and 2) pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity, improve WHO functional class and to delay clinical worsening. 
※資料Briefing Information | slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[PAH治療に承認すべきか?] Y=11,N=0,保留=0 [CTEPH治療に承認すべきか?] Y=11,N=0,保留=0
ADEMPAS (riociguat coated tablet)
  2013.08.05 204441, tolvaptan tablets, submitted by Otsuka Pharmaceutical Company, Ltd for the proposed indication of slowing kidney disease in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (autosomal dominant polycystic kidney disease is a genetic disease that affects the kidney and can lead to kidney failure). 
※資料Briefing Information | slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
tolvaptan
  2012.09.13 (NDA) 203009, lixivaptan, submitted by Cardiokine Biopharma, LLC, for the proposed indication of the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone (SIADH), respectively. 
※資料Briefing Information | slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
lixivaptan
  2012.09.13 NDA 203826, phenylephrine hydrochloride injection, USP, submitted by West-Ward Pharmaceutical Corp., to increase blood pressure in acute hypotensive states, such as shock and peri-operative hypotension. 
※資料Briefing Information | slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
phenylephrine HCl
  2012.05.23 (sNDA) 202439/S-002 XARELTO (rivaroxaban), submitted by Janssen Pharmaceuticals, Inc. to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS) [ST elevation myocardial infarction (STEMI), non-ST elevation myocardial infarction (NSTEMI), or unstable angina (UA)] in combination with aspirin alone or with aspirin plus clopidogrel or ticlopidine. 
※資料Briefing Information | slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
XARELTO (rivaroxaban)
  2012.02.13 (NDA) 203202, proposed trade name NORTHERA (droxidopa capsules), submitted by Chelsea Therapeutics, Inc., for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure (Parkinson's Disease, Multiple System Atrophy, and Pure Autonomic Failure), Dopamine Beta-Hydroxylase Deficiency, and Non-Diabetic Autonomic Neuropathy. 
※資料Briefing Information | slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
NORTHERA (droxidopa capsules)
1371 2011.09.08 (NDA) 202439, rivaroxaban tablets, submitted by Johnson & Johnson Pharmaceutical Research and Development, L.L.C., on behalf of Ortho-McNeil-Janssen-Pharmaceuticals, for the prevention of stroke and systemic embolism (blood clots other than in the head) in patients with non-valvular atrial fibrillation (abnormally rapid contractions of the atria, the upper chambers of the heart). 
※資料Briefing Information | slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[(非弁膜症心房細動患者で脳卒中および全身性塞栓症リスク低減) で承認すべきか?] Y=9,N=2,保留=1
rivaroxaban
  2011.05.02 the committees will discuss safety considerations of ultrasound contrast agents (materials intended to improve the clarity of ultrasound imaging), particularly related to new information and developments since the prior Advisory Committee meeting on the same topic on June 24, 2008. The discussion will include the results of required postmarketing safety studies and data from postmarketing surveillance. Specific drugs to be discussed include: (1) New drug application (NDA) 21-064, perflutren lipid microsphere injectable suspension, Lantheus Medical Imaging, Inc.; (2) NDA 20-899, perflutren protein-type A microspheres injectable suspension, GE Healthcare; and (3) the investigational new drug (IND) application for sulfur hexafluoride microbubble injection, Bracco Diagnostics, Inc. Perflutren lipid microsphere injectable suspension and perflutren protein-type A microspheres injectable suspension are indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border (improve the clarity of imaging of specific areas of the left lower side of the heart).  
※資料Briefing Information | slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
perflutren
  2010.12.08 The committee will discuss and provide general advice on the appropriate clinical study design for thromboxane receptor antagonists for prevention of cardiovascular events (such as heart attacks) in patients with aspirin intolerance due to immunologically-based adverse reactions (adverse events related to immune system function), specifically in the setting of coronary artery bypass grafting (also referred to as "heart bypass surgery"). 
※資料Briefing Information | slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
 
  2010.10.18 The committee will consider the results and analyses of the TREAT (Trial to Reduce Cardiovascular Events with Aranesp Therapy) study of ARANESP (darbepoetin alfa), manufactured by Amgen, Inc. This meeting is a follow-up to the September 2007 advisory committee meeting at which the committee discussed updated information on the risks and benefits of erythropoeisis-stimulating agents (drugs that stimulate production of red blood cells), marketed under the brand names ARANESP, EPOGEN, and PROCRIT, manufactured by Amgen, Inc., when used in the treatment of anemia (low red blood cell counts) due to chronic kidney failure. 
※資料Briefing Information | slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
ARANESP (darbepoetin alfa)
  2010.09.20 (NDA) 22-512, dabigatran etexilate mesylate capsules, sponsored by Boehringer Ingelheim Pharmaceuticals, Inc., for the proposed indication of prevention of stroke in patients with atrial fibrillation (abnormally rapid contractions of the atria, the upper chambers of the heart). 
※資料Briefing Information | slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
dabigatran
  2010.07.29 Revatio (sildenafil) for the treatment of pediatric pulmonary arterial hypertension (PAH) and whether to amend the clinical trials section of the written request, issued by FDA to Pfizer, to include assessment of a hemodynamic endpoint. An area of particular interest will be what the appropriate study endpoint should be in patients with PAH unable to perform exercise testing. The discussion will help the agency determine what studies to request for products intended to treat pediatric PAH. 
※資料Briefing Information | slides | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
Revatio (sildenafil)
1372 2010.07.28 (NDA) 22-433, ticagrelor tablets, 90 milligrams, manufactured by AstraZeneca LP, for the proposed indication for use in acute coronary syndrome (including heart attacks and any of a group of signs and symptoms, such as chest pain or shortness of breath, that are consistent with blockages in the blood vessels that supply the heart). 
※資料Briefing Information | slides | 議事録Transcripts 【審議結果】[PCI施行後の非ST上昇型、ST上昇型の急性冠症候群(ACS)に対する承認] Y=7,N=1,保留=
ticagrelor
1369-70 2010.03.01 (BLA) 125288, for belatacept injectable, by Bristol Myers Squibb, to be used in patients with kidney transplants to prevent rejection of the transplanted kidney. 
※資料Briefing Information | slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[腎移植の急性拒絶反応予防に承認すべきか?] Y=13,N=5,保留=0
belatacept
  2010.01.11 (sNDA) 21-742, nebivolol tablets, Forest Laboratories, Inc., for the proposed indication (use) of treatment of chronic heart failure. 
※資料Briefing Information | slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[nebivololは心不全の死亡・入院リスクを低下させるか?] Y=0,N=8,保留=0
nebivolol
  2009.12.08 The committees will discuss safety considerations related to FDA approved gadolinium-based contrast agents used with magnetic resonance imaging (MRI) scans. An MRI is a medical imaging technique that does not require x-rays. These scans outline the internal body structures such as organs and other soft tissues. Contrast agents are substances injected into the body before MRI scans, helping doctors to better see and interpret MRI findings. FDA approved gadolinium-based contrast agents include: gadobenate dimeglumine (MULTIHANCE), gadodiamide (OMNISCAN), gadopentetate dimeglumine (MAGNEVIST), gadoteridol (PROHANCE), gadoversetamide (OPTIMARK), gadoxetate disodium (EOVIST), and gadofosveset (ABLAVAR, previously known as VASOVIST). 
※資料Briefing Information | slides | 議事録Transcripts 【審議結果】
 
1337 2009.12.07 (NDA) 21-560, for everolimus oral tablets, by Novartis Pharmaceuticals Corporation, to be used in patients with kidney transplants to prevent rejection of the transplanted kidney. 
※資料Briefing Information | slides | 議事録Transcripts 【審議結果】[腎移植の拒絶反応予防に有効か?]Y=11,N=1
everolimus
  2009.07.29 (sNDA) 20-850/S-025, telmisartan tablets, 80 milligrams (mg), Boehringer Ingelheim Pharmaceuticals, Inc., for the proposed indication of reduction in the risk of myocardial infarction, stroke, death from cardiovascular causes, or hospitalization for congestive heart failure in patients 55 years or older who are at high risk of developing major cardiovascular events. 
※資料Briefing Information | slides | 議事録Transcripts
telmisartan
  2009.07.28 (NDA) 22-449, binodenoson injectable, lyophilized solid 250 micrograms vial, King Pharmaceuticals Research and Development, Inc., for the proposed indication: Short acting coronary vasodilator for use as an adjunct to noninvasive myocardial perfusion imaging tests to detect perfusion abnormalities in patients with known or suspected coronary artery disease. 
※資料Briefing Information | slides | 議事録Transcripts
binodenoson
1371 2009.03.19 (NDA) 22-406, rivaroxaban oral tablets (10 milligrams) Johnson & Johnson Pharmaceutical Research & Development, L.L.C., for the proposed indication for use in prophylaxis of deep vein thrombosis and pulmonary embolism in patients undergoing hip replacement surgery or knee replacement surgery 
※資料Briefing Information | slides | 議事要旨Minutes【審議結果】膝関節置換手術手術後の静脈血栓塞栓症(VTE)予防に対するRisk/Benefit上の好結果か? Y=15,N=2 /Rivaroxabanは腎・肝機能障害があり低用量10mgが望まれるが、これで治療効果は十分か? Y=5,N=9,保留=3
rivaroxaban
1322 2009.03.18 (NDA) 22-425, dronedarone 400 milligrams oral tablets, Sanofi Aventis, for the proposed indication in patients with a history of, or current atrial fibrillation or atrial flutter, for the reduction of the risk of cardiovascular hospitalization or death. 
※資料Briefing Information | slides | 議事要旨Minutes【審議結果】リスクファクターを伴う心房細動・心房粗動患者でdronedaroneが入院・死亡リスクを低減させうるかがポイントとなった。 dronedaroneは2005.6.10にNDA申請され、ADONISとEURIDISの二つのプラセボ比較試験では、不整脈の再発を遅らせるなどの効果を示した。この時の申請は主にANDROMEDA試験で発生した副作用(死亡率アップ)により不許可となった。 その後実施されたATHENA試験でdronedaroneはプラセボ対比で副作用を25%低減。 承認に対する賛否は Y=10,N=3,保留=0
dronedarone
1320 2009.02.03 (NDA) 22-307, prasugrel hydrochloride film coated oral tablets, 5 milligrams (mg) and 10 mg, Eli Lilly and Company, for the proposed indication for use in acute coronary syndrome. 
※資料Briefing Information | slides | 議事要旨Minutes【審議結果】Y=9,N=0 ※Prasugrel がclopidogrelに勝る点としてUA/NSTEMI(不安定狭心症unstable angina および非ST上昇心筋梗塞non-ST segment myocardialinfarction) およびSTEMI(ST上昇心筋梗塞)の双方に対する有効性。 一方clopidogrelに劣るのは出血リスク。
prasugrel
  2008.12.10 (NDA) 22-349, IMAGIFY (perflubutane polymer microspheres) injectable suspension, Acusphere Inc., proposed for use as an ultrasound imaging agent indicated for patients with stable chest pain being evaluated for inducible ischemia for the detection of coronary artery disease based on assessment of myocardial perfusion and wall motion. 
※資料Briefing Information | 議事要旨Minutes
IMAGIFY (perflubutane polymer microspheres)
  2008.06.24 discuss safety considerations in the development of ultrasound contrast agents, based upon the experience with the following: (1) New drug application (NDA) 21-064, perflutren lipid microsphere injectable suspension, Lantheus Medical Imaging, Inc.; (2) NDA 20-899, perflutren protein-type A microspheres injectable suspension, GE Healthcare; and (3) the investigational new drug application for sulphur hexafluoride microbubble injection, Bracco Diagnostics. Perflutren lipid microsphere injectable suspension and perflutren protein-type A microspheres injectable suspension are indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial borders. 
※資料Briefing Information | 議事要旨Minutes
 
1326 2008.06.25 (NDA) 22-275, tolvaptan (proposed trade name SAMSKA), Otsuka Pharmaceutical Development & Commercialization, Inc., for the proposed indication of treatment of hypervolemic and euvolemic, hyponatremia 
※資料Briefing Information | slides | 議事要旨Minutes 【審議結果】1)慢性の体液貯留型もしくは体液正常型の低ナトリウム血症患者に臨床上のベネフィットを期待できる十分なエビデンスがあるか? Y=8,N=3,保留=0 2)承認すべきか? Y=8,N=3,保留=0
tolvaptan
  2007.12.12 NDA 22-123, PULZIUM (tedisamil sesquifumarate) IV solution 2 mg per ml, Solvay Pharmaceuticals, Inc., for the proposed indication of use for conversion of atrial fibrillation or atrial flutter to normal sinus rhythm.
※資料Briefing Information | 議事録Minutes
PULZIUM (tedisamil sesquifumarate)
  2007.12.11 NDA 22-034, vernakalant hydrochloride injection, 20 milligrams (mg) per milliliter (ml), Astellas Pharma U.S., Inc., for the proposed indication of use for conversion of atrial fibrillation to normal sinus rhythm.
※資料Briefing Information | 議事録Minutes
vernakalant
(Astellas)
1280 2007.10.16 Regulatory considerations for extending the use of phosphate binders from the dialysis population (where they are approved) to the pre-dialysis population (where no products are approved). リン酸塩結合剤としてRenagel(塩酸セベラマーsevelamer HCl)[Genzyme Corp]、Fosrenol(炭酸ランサムLanthanum carbonate)[Shire Development]およびPhoslo(酢酸カルシウムCa acetate)[Fresenius Medical Care]について、現在いずれも「透析中の慢性腎不全患者における高リン血症の改善」を適応としているが、透析前の使用が適切かどうかを検討した。
※資料Briefing Information | 議事録Minutes【審議結果】[1.血清リン酸塩が透析前の患者の臨床アウトカムのサロゲイト・ポイントとなるか?]Y=0/N=14(諮問委は、薬剤による血清リン酸の低下を臨床上の改善と見なさない。) [2.血清リン酸塩が透析中の患者の臨床アウトカムのサロゲイト・ポイントとなるか?]Y=3/N=11(委員の大半が血清高リン酸値の治療に臨床上のベネフィットを認めているのだが、本療法の患者に骨疾患(二次性副甲状腺機能亢進症)が少ないと感じている者もいる。リン酸低下は患者にベネフィットとなる治療戦略の一部であるというのが、本諮問委の意見である) [3.リン酸塩結合剤のリスクについて]現時点では十分なデータがなく評決しない。 [4.リン酸塩結合剤の適応追加として透析前の投与を認めるか?]Y=8/N=4/保留=1 
Renagel
Fosrenol
  2007.09.12 [Drug Safety and Risk Management Advisory Committee合同]discuss clinical data for aprotinin injection (TRASYLOL, Bayer Pharmaceuticals), a product indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at increased risk for blood loss and blood transfusion.
※資料Briefing Information | 議事録Minutes
aprotinin(TRASYLOL, Bayer)
  2007.09.11 [Drug Safety and Risk Management Advisory Committee合同]discuss updated information on the risks and benefits of erythropoeisis-stimulating agents (ARANESP, Amgen, Inc., EPOGEN, Amgen, Inc., and PROCRIT, Amgen, Inc.) when used in the treatment of anemia due to chronic renal failure. This discussion follows a March 9, 2007
※資料Briefing Information | 議事録Minutes
epoetin
  sNDA) 20-758/S-037, AVALIDE (irbesartan plus hydrochlorothiazide), Bristol-Myers Squibb Co
※資料Briefing Information | 議事録Minutes
AVALIDE (irbesartan plus HCTZ)
  2006.9.21 NDA #20-304 TRASYLOL(R) (aprotinin injection)[Bayer] 冠動脈バイパス移植手術の間に心肺バイパスを受ける[CABG/CPB]患者で術後失血と輸血の必要性を抑える予防的使用の適応
※Brief Information
【審議結果】18-0-保留1で承認勧告※Final Minutes[議事録]
TRASYLOL(R) (aprotinin injection)[Bayer]
  2006.4.26 FDA Proposal On Relabeling Antihypertensive Drugs For Outcomes Claims; Meta-analysis Of Antihypertensive Placebo-Controlled Trials  
  2006.4.25 Cellegy Cellegesic Nitroglycerin Ointment For Anal Fissure Pain Relief  
1337 2005.11.16 Novartis Certican(everolimus) For Prophylaxis of Rejection In Heart Transplantation
2003.8と2004.8に"approvable letter"が発行され追加試験を要求され、その結果に基づき審議された。後者では低用量シクロスポリンとの併用により腎臓毒性リスクを最小にする臨床試験を要求されていた。 Novartis社は低用量シクロスポリンの研究をする代わりに、2年間の心臓移植Pivotal研究(B253)の24ヵ月延長試験を634例で実施。この試験ではステロイドと標準“full dose”シクロスポリンとCertican1日1.5mg & 3mg併用群に対してazathioprine, cyclosporine and corticosteroids群とを比較。 FDAはこの延長試験の脱落率と結果のアンバランスから試験デザインを問題視。 一方ノバルティス社はデータはeverolimusが心臓移植時の急性拒絶反応と同種移植血管症に対してアザチオプリンより明確にベネフィットを示していると主張。更にCerticanの副作用は移植専門医にとって十分管理しうるものであり、そのことは本剤が承認されている48ヵ国で実証されているとした。※Brief Information
【審議結果】ノバルティス社申請Regimenの心臓移植での有効性・安全性する評価を結論するにはデータが不十分であるとする提議に対して7−6の投票結果で承認勧告は否決された。※Summary Minutes[議事録]
★欧州ではスエーデン(2003.7 心臓・腎臓移植時の拒絶反応抑制;MRP方式)が最初で、2003.12にMRPプロセスが承認され欧州15ヵ国での使用が認可された。
★Certicanの投薬中止は10-22%で貧血、感染、leucopenia, thrombocytopenia 等の副作用による
Certican(everolimus)
1218 2005.06.16 NitroMed BiDil For Heart Failure Based On African American Heart Failure Trial
[審査結果]全員一致で承認勧告※Brief Information
BiDil
(ISDN+Hydralazine)
  2005.06.15 Antihypertensive Class Labeling Based On Outcome Trials
※Brief Information
 
  2005.02.24 AstraZeneca Atacand For Reduction Of Cardiovascular Mortality/Hospitalization In Congestive Heart Failure
※Brief Information
 
  2004.09.10 AstraZeneca Exanta For Prevention Of Venous Thromboembolism
※本剤は抗血液凝固剤(Anticoagulant)で、効果メリットと肝臓毒性とのバランスが審議された。
※[審議結果]本剤は3ツの適応症を求めていた。 1)心房細動を伴う脳卒中等の血栓塞栓症の長期間予防 2)急性エピソードの標準療法後の静脈塞栓症の長期間二次予防 3)膝関節置換手術を施行する患者の静脈塞栓症の短期予防。 これについて1&2は11-1で承認勧告。 3)は否認された。 Brief Information
Exanta (ximelagalatran)
  2003.12.08 Aspirin For Primary Prevention Of Mycardial Infarction
※バイエル社が2003.2.11付けで市民請願"expanded cardiovascular indications and [professional] labeling for the use of an aspirin regimen (75 mg-325 mg) to reduce the risk of a first myocardial infarction"をファイル。現在病医院向けアスピリンはMIの二次予防に推奨されている。
※[審議結果]11-3で否決。
Aspirin
  2003.12.09 CV Therapeutics Ranexa For Angina[★中止]
※本剤は2002.12.30にchronic anginaへの適応で申請
※[審議結果]refractory(再発) angina patientsに制限した適応で承認勧告
(ranolazine)
  2003.11.20 Boston Scientific Taxus Paclitaxel-Eluting Stent
※Brief Information※[審議結果]8-0でPMA承認勧告
 
1166
1173
2003.05.29 Bayer Levitra, Sanofi UroXatral QT Prolongation Issues
※ED(勃起不全治療薬)剤Levitra (vardenafil)は、2002.7以来"Approvable"とされてきたのだが.QT prolongationが問題視されていた。EUは2003.3.7承認済み
※UroXatral (alfuzosin),欧州商品名Xatral ODは1日1回投与持続性α遮断剤のBPH治療薬で欧州では1988年以来承認。これもQT延長が問題視。
※審議の結果、委員の多数はQT延長は臨床上問題ないレベルとした※Brief information
Levitra (vardenafil)
UroXatral (alfuzosin)
  2003.01.06 Merck Cozaar CV Morbidity & Mortality Risk Reduction Indication
※単独5-5,β遮断剤併用9-1で承認勧告(10%低下)
※Brief Information
losartan
  2003.01.07 GlaxoSmithKline Coreg For Reduction Of Post-MI Heart Attack Risk
※左心室機能不全患者の心筋梗塞後死亡率低下に承認勧告(23%低下)
※Brief Information
carvedilol
  2002.11.25 Combination Products Regulatory Policy  
  2002.10.22 J&J/Cordis Cypher Drug-Eluting Stent  
  2002.07.19 Bristol Vanlev For Hypertension  
  2002.07.18 Atacand vs. Cozaar Label Claim; Pravastatin/Aspirin Co-Package  
  2002.04.12 Merck Cozaar For Nephropathy In Type 2 Diabetics  
  2002.01.18 Pravachol/Aspirin Co-package Committee Review  
  2002.01.17 Bristol Avapro For Renal Disease Prevention In Diabetics (irbesartan)
  2001.10.11 Novartis Diovan For Heart Failure (varsartan)
1127 2001.08.10 Actelion Tracleer For Pulmonary Hypertension
※【審議結果】全員一致で承認勧告※Brief Information
(bosentan)
1139 2001.08.9 Remodulin and Extraneal Committee Reviews
※【審議結果】6:3で承認勧告※Brief Information
(Treprostinil Sodium)
1118 2001.05.25 Scios Natrecor For Congestive Heart Failure
※資料Briefing Information | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
(Nesiritide)
  2001.05.24 Pfizer Cardura Second-Line Use Petition (doxazosin mesylate)
BPH,高血圧治療剤
  2000.10.20 Antihypertensive Dose Response Measures  
1036 2000.05.2 Aventis Refludan Committee Review (Lepirudin)FDA承認6-Mar-1998
  2000.05.1 King Altace Committee Review (ramipril)
ML 開催日 議題 備考
     
  2014.05.07 the committee will discuss and make recommendations regarding the classification of Membrane lung for long-term pulmonary support systems, one of the remaining preamendments Class III devices regulated under the 510(k) pathway. A membrane lung for long-term pulmonary support refers to the oxygenator component of an extracorporeal circuit used during long-term procedures, commonly referred to as an ECMO. An ECMO procedure provides assisted extracorporeal circulation and physiologic gas exchange of a patient's blood when an acute (reversible) condition prevents the patient's own body from providing the physiologic gas exchange needed to sustain life. 
※資料FDA Executive Summary| FDA slides - ECMO - FDA slides - Device Classification | 議事要旨Minutes | 【審議結果】[] Y=,N=,保留=
  2014.05.06 the premarket approval application for the RESQCPR System sponsored by Advanced Circulatory Systems, Inc. The RESQCPR System is comprised of two devices: the RESQPOD 16.0 Impedance Threshold Device (ITD), and the RESQPUMP Active Compression Decompression CPR (ACD-CPR) Device. These devices are used together during manual CPR in an attempt to enhance venous return to the heart and blood flow to vital organs during CPR to ultimately increase survival and neurologic outcome in patients suffering from out of hospital cardiac arrest 
※資料 FDA Executive Summary| Sponsor slides - FDA slides | 議事要旨Minutes | 【審議結果】[] Y=,N=,保留=
RESQCPR System
  2013.12.11 Boston Scientific WATCHMAN® Left Atrial Appendage Closure Therapy 
※資料Briefing Information | Sponsor Executive Summary - FDA Executive Summary| Sponsor slides - FDA slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
Boston Scientific WATCHMAN® Left Atrial Appendage Closure Therapy
  2013.10.09 CardioMEMS Champion HF Monitoring System 
※資料Briefing Information | FDA Executive Summary| Sponsor slides - FDA slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
Champion HF Monitoring System
  2013.10.08 Expanded Indications for Medtronic Cardiac Resynchronization Therapy Devices - Therapy-Pacemaker (CRT-P) and Cardiac Resynchronization Therapy-Defibrillator (CRT-D) devices. 
※資料Briefing Information | FDA Executive Summary| Sponsor slides - FDA slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
CRT-D,CRT-P
  2013.09.12 the committee will discuss and make recommendations regarding the proposed classification of Membrane lung for long-term pulmonary support systems (ECMO), one of the remaining preamendments Class III devices regulated under the 510(k) pathway. A membrane lung for long-term pulmonary support refers to the oxygenator component of an extracorporeal circuit used during long-term procedures, commonly referred to as an ECMO. An ECMO procedure provides assisted extracorporeal circulation and physiologic gas exchange of a patient's blood when an acute (reversible) condition prevents the patient's own body from providing the physiologic gas exchange needed to sustain life. ECMO is intended for patients with acute reversible respiratory or cardiac failure, unresponsive to optimal ventilation and/or pharmacologic management. 
※資料ECMO Executive Summary| FDA slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
Membrane lung for long-term pulmonary support systems (ECMO)
  2013.09.11 the committee will discuss and make recommendations regarding the proposed classification of External Cardiac Compressor (ECC) devices, one of the remaining preamendments Class III devices regulated under the 510(k) pathway. External cardiac compressors (ECCs), also known as chest compressors, assist in the act of cardiopulmonary resuscitation (CPR). The devices in this classification are divided into two types: (1) Devices that provide automatic chest compressions at a fixed compression rate and depth (automated external cardiac compressors), which are placed directly on the patient's chest and are powered manually, pneumatically, or electrically and (2) devices that aid the emergency medical professional in delivering manual compressions at a compression depth and rate that are consistent with current guidelines (CPR Aids). 
※資料EPPG TCPSA Executive Summary - ECC Executive Summary| EPPG TCPSA slides - ECC slides1 - ECC slides2 | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
External Cardiac Compressor (ECC) devices
1432 2013.03.20 Abbott Vascular MitraClip Clip Delivery System (MitraClip CDS). P100009
※資料Briefing Information | Sponsor Executive Summary - FDA Executive Summary|議事要旨Minutes | 議事録Transcripts 【審議結果】[1.安全性] Y=8,N=0,保留=0 [2.有効性] Y=4,N=5,保留=0 [3.ベネフィット] Y=5,N=3,保留=0
MitraClip CDS
  2012.12.06 recommendations regarding the 515(i) order issued by the Food and Drug Administration on April 9, 2009 [Docket No. FDA-2009-M-0101], for Nonroller-type cardiopulmonary bypass blood pumps, one of the remaining pre-Amendment Class III devices. A nonroller-type cardiopulmonary bypass blood pump is a device that uses a method other than revolving rollers to pump blood. 
※資料IABP Executive Summary - NRP Executive Summary| IABP slides - NRP slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
IABP,NRP
  2012.12.05 external counter-pulsating (ECP) devicesの再分類 
※資料FDA Executive Summary| FDA slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
external counter-pulsating (ECP) devices
  2012.06.13 Edwards SAPIEN Transcatheter Heart Valve - P110021 
※資料Briefing Information | Sponsor Executive Summary - FDA Executive Summary| Sponsor slides1 - Sponsor slides2 - Sponsor slides3 - FDA slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
Edwards SAPIEN Transcatheter Heart Valve
  2012.05.24 Transcatheter ASD Occluders: Clinical Update and Review of Events 
※資料Sponsor Gore: Panel Pack - Sponsor St. Jude: Panel Pack | FDA Executive Summary - FDA Executive Summary appendics| slides - Gore - slides - St.Jude - FDA slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
Transcatheter ASD Occluders
  2012.04.26 Cameron Health Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) 
※資料Sponsor Executive Summary - FDA Executive Summary| slides - FDA slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
Cameron Health Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
  2012.04.25 HeartWare Ventricular Assist System (VAS) 
※資料Sponsor Briefing Information | FDA Executive Summary| slides - FDA slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
HeartWare Ventricular Assist System (VAS)
  2011.12.08 ChampionTM HF Monitoring System 
※資料Sponsor Briefing Information | Sponsor Brief Summary - Addendum | FDA Brief Summary - Addendum | slides - FDA slides| 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
ChampionTM HF Monitoring System
  2011.12.07 Medtronic REVERSE CRT-D 
※資料Briefing Information | FDA Brief Summary | slides - FDA slides| 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
REVERSE CRT-D
  2011.10.27 Medtronic Cardiac Ablation System P100008 
※資料Briefing Information | FDA Brief Summary | slides - FDA slides| 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
Medtronic Cardiac Ablation System
  2011.10.26 AtriCure Synergy Bipolar Ablation System 
※資料Briefing Information | FDA Brief Summary | slides - FDA slides| 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
AtriCure Synergy Bipolar Ablation System
  2011.10.13 Zilver-PTX Drug-Eluting Peripheral Stent[Cook Inc.] 
※資料Sponsor Briefing Information | FDABrief Summary | Sponsor slides -FDA slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
Zilver-PTX Drug-Eluting Peripheral Stent
  2011.07.21 Berlin Heart EXCOR Pediatric Ventricular Assist Device 
※資料Briefing Information | FDA Brief Summary | Sponsor slides - FDA slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
Berlin Heart EXCOR Pediatric Ventricular Assist Device
  2011.07.20 Edwards SAPIEN Transcatheter Heart Valve P100041 
※資料Briefing Information | FDA Brief Summary | slides - FDA slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
Edwards SAPIEN Transcatheter Heart Valve
  2011.01.26 RX Acculink Carotid Stent System[Abbott] 
※資料Briefing Information | FDA Brief Summary | slides - FDA slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
RX Acculink® Carotid Stent System
  2011.01.25 Automated External Defibrillators[AED]再分類 
※資料Brief Summary | slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
Automated External Defibrillators[AED]
  2010.03.19 Medtronic Inc. REVO MRI FDA-Generated 
※資料Briefing Information - Appendix Summary| Brief Summary | slides - slide2| 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
REVO MRI
  2010.03.18 Boston Scientific Inc. MADIT CR Non-FDA Generated 
※資料Briefing Information | Brief Summary | PAS slides - FDA slides| 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
MADIT CR
  2009.07.23 REPEL-CV resorbable, cardiac adhesion barrier device 
※資料Briefing Information | Brief Summary | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
REPEL-CV
  2009.07.22 recommendations, and vote on a Humanitarian Device Exemption (HDE) application, sponsored by Medtronic, Inc., for the MEDTRONIC MELODY Transcatheter Pulmonary Valve (Model PB10) and MEDTRONIC ENSEMBLE Transcatheter Valve Delivery System (NU10). The MEDTRONIC MELODY Transcatheter Pulmonary Valve (Model PB10) and MEDTRONIC ENSEMBLE Transcatheter Valve Delivery System (NU10) is indicated for use in patients with the following clinical conditions: Regurgitant (insufficient or leaky) Right Ventricular Outflow Tract (RVOT) - The right ventricular outflow tract is that portion of the right ventricle leading up to the pulmonary valve and pulmonary artery. When the ventricles contract, blood moves along the outflow tract and through the pulmonary valve; blood then flows to the lungs where gas exchange takes place.  
※資料Briefing Information | Brief Summary | slides1 - slides2 | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
Humanitarian Device Exemption (HDE)
  2009.04.23 WATCHMAN Left Atrial Appendage (LAA) Closure Technology[Atritech, Inc] 
※資料Briefing Information | Brief Summary |議事録Transcripts 【審議結果】[] Y=,N=,保留=
WATCHMAN Left Atrial Appendage (LAA) Closure Technology
  2009.03.18 TherOx Aqueous Oxygen System (AO System)[TherOx, Inc] 
※資料Briefing Information | Brief Summary | slides 【審議結果】[] Y=,N=,保留=
TherOx Aqueous Oxygen System (AO System)
  2008.11.20 NaviStar ThermoCool irrigated RF ablation catheter[Webster, Inc., a Johnson & Johnson Company] 
※資料Briefing Information | Brief Summary | slides | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
NaviStar ThermoCool irrigated RF ablation catheter
  2007.11.30 HeartMate II Left Ventricular Assist System (LVAS)[Thoratec Corporation] 
※資料Brief Summary | slides | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
HeartMate II Left Ventricular Assist System (LVAS)
  2007.11.29 XIENCE V Everolimus Eluting Coronary Stent System[Abbott Vascular] 
※資料Briefing Information | Brief Summary | slides | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
XIENCE V Everolimus Eluting Coronary Stent System
  2007.10.11 recommendations regarding clinical trial designs for carotid artery stenting in patients not at high risk for adverse events from surgical revascularization 
※資料Briefing Information | Brief Summary | slides | | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
 
  2007.10.10 Endeavor Zotarolimus-Eluting Coronary Stent System[Medtronic,] 
※資料Briefing Information | Brief Summary | slides | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
Endeavor Zotarolimus-Eluting Coronary Stent System
  2007.09.20 recommendations regarding clinical trial designs for cardiac ablation devices designed to treat patients with medically refractory atrial fibrillation 
※資料Briefing Information | Brief Summary | slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
 
  2007.09.19 REPEL-CV[SyntheMed, Inc.] 
※資料Briefing Information | Brief Summary | slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
REPEL-CV
  2007.06.27 CryoCor Cryoablation System[CryoCor Inc] 
※資料Briefing Information | Brief Summary | slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
CryoCor Cryoablation System
  2007.03.02 Patent Foreman Ovale closure devices  
※資料Briefing Information | Brief Summary | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
 
  2007.03.01 P050032-Chronicle Implantable Hemodynamic Monitoring System[Medtronic]
※資料Briefing Information | Brief Summary | 議事要旨Minutes | 議事録Transcripts1 - [2] - [3] - [4] - [5] 【審議結果】[] Y=,N=,保留=
 
  2006.12.08 drug eluting stents-DES Thrombosis Panel 
※資料Briefing Information | slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
drug eluting stents-DES
  2006.12.07 drug eluting stents-DES Thrombosis Panel 
※資料Briefing Information | slides | 議事要旨Minutes | 議事録Transcripts 【審議結果】[] Y=,N=,保留=
drug eluting stents-DES
  2005.06.23 Abiomed, Inc. H040006: Abiocor Implantable Replacement Heart
※世界初の完全人体埋め込み型の人工心臓。現在10万ドルの費用がかかるが、承認されれば2.5万ドル程度となると予想。因みに大きいので女性や日本人には無理で同社では更に小型化を模索中。※Brief Information※【審議結果】humanitarian device exemption (HDE)の評価基準に適合しないとして否決。投票は7-6で棄権1(条件付承認では7-7だった)。 問題とされたのは高い神経学的な有害事象で、14例のうち12例が手術を生き延びたが、12名中10例が一過性虚血発作transient ischemic attack(TIA) または脳卒中に悩まされている。 ※【HDEとは】医療機器の倫理関連ガイダンスはFDA Humanitarian Device Exemption (HDE) Regulation[2006.7.18]参照。 米国連邦食品医薬品化粧品法(FDC Act: 日本の薬事法に相当)section 510(m)(2)にHDEおよびHumanitarian Use Device (HUD)事項が規定され人道倫理面での医療機器の使用に枠をはめている。つまり諮問委でHDEを話題にする時は、一般論ではなく法的に適法かどうかを論議している。 用語HDEは日本に該当法がなく直訳すると「人道的医療用具免責条項」だが意味不明になるので「ヒトゲノム・遺伝子解析研究に関する倫理指針」等の日本式に言うとHDE規則は「医療用具の臨床試験に関する例外規定」とでも訳すのが適切。 現実問題として日本の場合は新薬事法など大枠内での配慮がなされているわけでHDE法案が別に立案されというのは日本的ではない。※[参考]治療の歴史「人工心臓の開発」
 
  2005.06.22 Acorn Cardiovascular P040049: CorCap CSD
※重症心不全の拡大した左室の形状とサイズおよびQOLを改善。メッシュ状のファイバーで心室を包んでリモデリングを抑制。※Brief Information※【審議結果】9-4で承認勧告。
 
  2005.04.22 PAS-Port Proximal Anastomosis System by Cardica, Inc.,
※※Brief Information※【審議結果】
 
  2005.03.17 CoolGard 3000/Icy Heat Exchanger Catheter Thermal Regulating System by Alsius Corporation
※※Brief Information※【審議結果】
 
  2005.01.13 GORE TAG Thoracic Endoprosthesis
※※Brief Information※【審議結果】
 
  2004.09.21 CPR[cardiopulmonary resuscitation]-Enhancing Device Studies Require Follow-Up Through Hospital Discharge
※自動体外除細動器(AED)と異なリ、第三世代CPR増強装置である心肺機能回復装置等は、まだFDA承認されていない。 1988.6 諮問委はAmbu's CardioPumpをCPR補助用にPMA承認勧告したが提出データについて多数の点で批判するという誤謬を犯した。
※[審議結果]CPR増強装置の臨床効果Endpoint研究に関して心停止患者生存率について退院まで調査する必要がある。Brief Information
 
1241-2 2004.07.29 Philips Medical System Heartstart Home OTC Defibrillator
※心臓突然死Sudden cardiac arrest (SCA)は死因の上位を占め、徐細動器が手近にないことから心停止が発生した時の生存率は5%以下。Philips Medical Systemsの調査では80%が自宅で発生し50%以上が手近に補助可能な人がいる。 今回審議対象のHeartStart Home Defibrillatorは2002.11にFDA承認された最初の新世代徐細動器。 ※Brief information※【審議結果】承認勧告。 ※【参考】日本では心突然死に対する救命手段として、厚生労働省が2001年12月に航空機乗務員に対し、翌年4月には包括的指示のもと救急救命士に対してもAEDの使用を認め、更には一般市民にまでAEDの使用が2004年7月1日に認められました(Public Access Defibrillation)。従来、医師のみの使用に限られていた除細動器は、毎年20億円程度のマーケットでしたが、一昨年から、急激な除細動器市場の拡大が始まっております。既に成熟市場と言われている米国のAEDマーケットは、現在も年10%以上の成長を続けており、年200億円の市場規模に達しています。[2004.7]; [フィリップス メディカル システムズ]一般市民向けAED「ハートスタートHS1」
 
  2004.07.28 Guidant Cardiac Resynchronization Defibrillator
※同社cardiac resynchronization therapy defibrillator (CRT-D) は全死因の36%リスク低減させると謳っている。このPMA追加申請はGuidant社の128施設1,520患者の臨床試験COMPANIONに基づきContak Renewal 3等のCRT-Dの適応拡大を求めるもの。※Brief information※【審議結果】8-0 全員一致で承認勧告。※【参考】除細動機能持つCRT‐Dが日本初登場;植込み型除細動器(ICD)について;植込み型心臓ペースメーカおよび植込み型除細動器に関する重要な発表について[2006.6.27]
 
  2004.06.08 WorldHeart Announces Novacor June 8 Panel Review For Expanded Indication
※埋め込み型左室補助人工心臓システム(ノバコア)は現在米国で「心臓移植までのつなぎ(ブリッジ)」として認可されているが、今回の適応拡大は「LVAD(=Left Ventricular Assist Device: 左心室補助装置)の補助により心臓移植が可能となる移植不適合患者」についてのもの。 FDAは2002.11のPMA追加申請を却下しており、その後WorldHeart社がINTrEPID trialを実施しその結果を基に再申請したもの。 ※日本では、重症心不全の患者さんで、従来の治療法(薬物療法や既存の補助循環法)にも拘らず継続した代償不全に陥っており、かつ、心臓移植以外には救命が困難と考えられる症例に対する循環改善に使用される目的で、承認されている。※[参考資料][治療の歴史]人工心臓の開発| 人工心臓 ノバコア補助人工心臓について
 
  2004.04.21 Precise Carotid Stent With Angioguard Embolic Protection System[Cordis社;販売J&J](Angioguard塞栓防護システム付属の精密頸動脈ステント)
※AngioGuardによる成功率は95.6%。
※同種品Acculink and Rx Accunet[Guidant社]、FilterWire EZ [Boston Scientific] も大規模臨床試験を実施している。
※[審査結果]6-5で承認勧告。
 
  2004.03.18 Aortic Anastomotic Device Clinical Trials For Cardiac Bypass(心臓バイパス手術用大動脈吻合手術機器の臨床試験に関する審議)
※FDAは低侵襲性心臓バイパス手術式の開発に際しての重要なステップとなる吻合コネクター技術でJumpstart研究を行おうとしている。 Symmetry[St.Jude社]が2000年にFDAクリア。
 
  2004.03.17 SynCardia CardioWest Artificial Heart
※人工心臓のレビュー。 TAHは不可逆性両心室性不全による切迫した危険[iminent peril]にある患者に移植するための、院内bridgeとして考案されたもの。
CardioWest Total Artificial Heart (TAH)
  2003.11.20 TAXUS(TM) Express2(TM) (SR) Paclitaxel-Eluting Monorail and Over-the-Wire Coronary Stent Systems[Boston Scientific]
※[審議結果]8-0でPMA承認勧告
※[適応]for improving luminal diameter[管腔径] and reducing restenosis[再狭窄] for the treatment of de novo lesions[デノボ損傷].
※同社はTexus-パクリタキセル溶出ステントの糖尿病患者への適用を強調。
 
  2003.10.02 CLiRpatha Excimer Laser Catheters[Spectranetics Corp]  
  2003.05.29 REVELATIONR(R) Tx Microcatheter Ablation System[Cardima Inc.]  
  2003.04.10 Endovascular Graft[Zenith]: Suggested Instructions for Use  
  2003.03.06 Freezora(TM) Cryoablation寒冷剥離 Catheter System P020045[CryoCath Technologies Inc]  
  2002.10.23 K022071, EMBOL-X Aortic Filter  
  2002.10.22 P020026, CYPHER(TM) Sirolimus-Eluting Coronary Stent System  
  2002.09.10 P000049/S3 CardioSEAL(R) STARFlex(TM) Septal Occlusion System With Qwik Load Instructions For Use for Transcatheter PFO Closure[Nitinol Medical Technologies]※心房中隔欠損閉鎖用のCardioSEAL(R)を転用。NMT社は最近,SEALの第3世代に当たるSTARflexを開発した。同機器は2枚の繊維製ディスクとその間を貫く4個のフレキシブルスプリングで構成されている。また,自動センタリング機構が組み込まれ,自動制御で開存孔の中心部に位置できるよう改良されている。カテーテルにもさらなる改良が加えられ,デバイスの誘導・位置決めが容易にできるようになった。  
  2002.09.09 Excluder Bifurcated Endoprosthesis  
  2002.03.05 P010031, Medtronic(R) InSync ICDR System Model 7272  
  2002.03.04 P910014/S016, HeartMate VE LVAS[Thoratec Corporation]  
  2001.09.11 BioGlue(R) Surgical Adhesive  
  2001.09.10 P000039 AMPLATZER(R) Septal Occluder and Delivery System  
  2001.07.10 PMA P970029/S004-Eclipse Surgical Technologies, Inc. Percutaneous Myocardial Revascularization (PMR) Holmium Laser System  
  2001.07.09 an update on two approved premarket approval applications (PMAs) for endovascular grafts−the Guidant Endovascular Solutions Ancure Endograft System (P990017) and the Medtronic AVE AneuRx Stent Graft (P99000220).  
  2001.04.23 P000033, IntraCoil Self-Expanding Peripheral Stent[Sulzer IntraTherapeutics, Inc]  
  2001.02.05 Percusurge Guardwire Plus(R) Temporary Occlusion & Aspiration System  
  2000.12.05 Medtronic Model 7250 Jewel AF Implantable Cardioverter Defibrillator System, P980050/S1  
  2000.12.04 PTCA Catheter Reclassification Panel  
  2000.09.11 Novoste Intravascular Brachytherapy System Beta-Cath(TM) System[Novoste Corporation]  
  2000.06.20 Implantable Cardioverter Defibrillators[Medtronic]  
  2000.06.19 CORDIS Radiation System Checkmate[TM] PMA#P990036  
  2000.04.04 The Least Burdensome Provisions of the FDA Modernization Act of 1997
Study Design for Spinal Cord Stimulation (SCS) for Angina
Rate Adaptive Pacemakers[Medtronic]
Atrial Fibrillation Device Therapies
 
ML 開催日 議題 備考
     
   
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts【審議結果】Y=,N=0,保留=
 
1483 2015.03.09 (NDA) 206333, deoxycholic acid injection, a cytolytic drug, submitted by Kythera Biopharmaceuticals, proposed for the improvement in the appearance of moderate-to-severe convexity or fullness associated with submental fat in adults. During the afternoon session, the committee will discuss pediatric development of systemic products for the treatment of atopic dermatitis with inadequate response to topical prescription therapy. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts - 2【審議結果】[有効性と安全性から承認すべきか?]Y=17,N=0,保留=0
deoxycholic acid
  2015.02.24 (NDA) 203324, for riboflavin ophthalmic solutions with UV-A irradiation, submitted by Avedro, Inc. The combination products are used in corneal collagen cross-linking and proposed to be indicated for the treatment of progressive keratoconus or corneal ectasia following refractive surgery. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts【審議結果】Y=,N=0,保留=
riboflavin
1465 2014.10.20 (BLA) 125504, secukinumab, a human monoclonal antibody, submitted by Novartis, proposed for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.  
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts【審議結果】[承認可否]Y=7,N=0,保留=0
secukinumab
  2012.07.26 a supplement to biologics license application (BLA) 125156 for LUCENTIS (ranibizumab) injection by Genentech, Inc., for the treatment of diabetic macular edema (DME). Ranibizumab injection is currently approved for the treatment of neovascular (wet) age-related macular degeneration (AMD) and macular edema following retinal vein occlusion (RVO). 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts【審議結果】[0.3mgと0.5mg間に臨床的有効性差はあるか?]Y=0,N=10,保留=0 [0.3mgと0.5mg間に臨床的安全性差はあるか?]Y=4,N=4,保留=2 [有効性が実証されたか?]Y=10,N=0,保留=0 [安全性の追加試験は必要?]Y=0,N=9,保留=1 [月1回0.5mg投与で承認すべきか?]Y=8,N=2,保留=0 [月1回0.3mg投与で承認すべきか?]Y=10,N=0,保留=0 [ラベルに関しSuggestionがあるか?]Y=7,N=2,保留=1
LUCENTIS (ranibizumab)
1422 2012.07.26 (BLA) 125422, ocriplasmin intravitreal injection (proposed tradename, Jetrea) by ThromboGenics, Inc., indicated for the treatment of symptomatic vitreomacular adhesions (sVMA) including macular hole. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts【審議結果】[硝子体黄斑癒着への有効性が実証されたか?]Y=10,N=0,保留0= [硝子体黄斑癒着に伴う黄斑円孔への有効性が実証されたか?]Y=7,N=3,保留=0 [黄斑癒着に拘わらず黄斑円孔への有効性が実証されたか?]Y=1,N=8,保留=1 [網膜への安全性の追加試験は必要か?]Y=3,N=6,保留=1 [硝子体黄斑癒着に対してリスクを上回るベネフィットはあるか?]Y=10,N=0,保留=0
ocriplasmin
  2012.02.27 on the appropriateness of marketing a single bottle of anti-inflammatory ophthalmic products for use in both eyes for post-surgical indications as it relates to the potential risk for infection 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts【審議結果】Y=,N=0,保留=
 
  2011.12.01 【午前】REMS program for isotretinoin, also known as iPLEDGE, as an example of a REMS that has ETASU 
【午後】the impact of REMS with ETASU on the healthcare system and patient access, such as how programs with ETASU can be better integrated into existing health systems. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts1 - Transcripts2 【審議結果】Y=,N=0,保留=
isotretinoin
1383 2011.06.17 (BLA) 125387, aflibercept ophthalmic solution, proposed trade name EYLEA, sponsored by Regeneron Pharmaceuticals, Inc., indicated for the treatment of neovascular age-related macular degeneration (wet AMD). 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts【審議結果】[安全性と有効性]Y=10,N=0,保留=0
aflibercept
1331 2009.06.26 NDA 22-288 - Bepreve (Bepotastine Besilate Ophthalmic Solution, 1.5%, ISTA Pharmaceuticals Inc.)Indication: Treatment of ocular itching associated with allergic conjunctivitis
※資料Briefing Information | Slides1 | 議事要旨Minutes | 議事録Transcripts1【審議結果】Y=7,N=0,保留=0
Bepotastine
  2009.06.26 Sodium hyaluronate ophthalmic solution 0.18% River Plate Biotechnology, Inc/ Indication: For the treatment of the signs and symptoms of dry eye disease
※資料Briefing Information | Slides2 | 議事要旨Minutes | 議事録Transcripts2【審議結果】Y=1,N=6,保留=0
Sodium hyaluronate
  2008.12.05 (NDA) 22-308, besifloxacin ophthalmic solution, Bausch & Lomb, Inc., proposed for the treatment of bacterial conjunctivitis 
※資料Briefing Information | Slides | 議事要旨Minutes【審議結果】Y=9,N=0
bimatoprost
1313 2008.12.05 Session 2: The committee will discuss new drug application (NDA) 22-369, bimatoprost ophthalmic solution, 0.03%, Allergan, Inc., proposed for the treatment of hypotrichosis of the eyelids. 
※資料Briefing Information | 議事要旨Minutes
besifloxacin
  2008.06.18 (sBLA) 103795/5350, etanercept, a lyophilized powder for subcutaneous injection, Immunex Corp., proposed for the treatment of moderate to severe psoriasis in the pediatric population. 
※資料Briefing Information
etanercept
  2008.06.17 (BLA) 125261, ustekinumab, a human monoclonal antibody, Centocor, Inc., proposed for the treatment of moderate to severe psoriasis.
※資料Briefing Information
ustekinumab
  2008.05.29 NDA22-212, difluprednate ophthalmic emulsion, Sirion Therapeutics, Inc., proposed for the treatment of inflammation and pain following ocular surgery
※資料Briefing Information | 議事録Transcript
difluprednate
  2007.08.01 iPLEDGE, the risk management program for isotretinoin products
※資料Briefing Information | 議事録Transcript1 | Transcript2 | Transcript3
isotretinoin
  2005.03.24 Topical Corticosteroid Rx-To-OTC Switch Safety Data※外用ステロイドのOTCスイッチに関して視床下部−下垂体−副腎(HPA)系に対する影響強度および成長抑制等の副作用問題が審議された。HPA軸機能抑制は突然死の原因になる。
【審議結果】HPA軸機能抑制を起こすステロイドはOTC Switch対象としない(投票21-5)。※Brief Information | Slides - FDA Experience: Topical Corticosteroids and HPA Axis Suppression
 
1212 2004.08.27 Pfizer/Eyetech Macugen For "Wet" Age-Related Macular Degeneration
※本剤はVEGF(vascular endothelial growth factor) inhibitor
※資料Briefing Information | Slides | 議事録Transcripts【審議結果】好意的反応だったが、長期試験を追加要請。 FDA Brief Information
Macugen (pegaptanib sodium)
  2004.07.12 Allergan Tazoral For Moderate To Severe Psoriasis
※Dermatologic & Ophthalmic and Drug Safety & Risk Management Committees合同
※[審議結果]本剤の強い催奇形性のため、リスク管理プログラムの研究が要請された。 リスク管理プログラムおよび安全問題に関する不確実性のため、棄権4,9-3で効果・安全性バランスは否定された。 
Tazoral(tazarotene)
  2004.05.06 Athlete's Foot (Interdigital Tinea Pedis指間・足部白癬) OTC Products: Efficacy, Labeling Issues - Day 1
※12才以上の患者での効能とラベル表示について審議する。 Schering-Plough's Lotrimin Ultra (butenafine hydrochloride) and Novartis' Lamisil AT (terbenafine hydrochloride) cream and solution(発売クリーム1999、液2000)については指間Claim; Lotrimin Ultra(2002発売)ラベルclaims"Cures most athlete’s foot (tinea pedis) between the toes. Effectiveness on the bottom or sides of the foot is unknown"; これらは全部Rx-OTCスイッチ製品
 
  2004.05.07 Athlete's Foot (Interdigital Tinea Pedis) OTC Products: Efficacy, Labeling Issues - Day 2  
  2004.02.27 Accutane Risk Management - Day 2
※会議記録 | 資料Briefing Information | 議事録Transcript 2/26 & Transcript 2/27
Accutane (isotretinoin)
  2004.02.26 Accutane Risk Management - Day 1
※Dermatologic & Ophthalmic and Drug Safety & Risk Management Committees合同
※ロシュ社で2年前に採用された'SMART' program (System to Manage Accutane Related Teratogenicity)に関して審議の一年後レビュー結果が"minimal to no improvement."であるとして、FDAは妊娠予防を含めて、修正したisotretinoin risk management programs (RMPs)iPLEDGEを求めた。 このRMPs結果について審議する。 ここでは、イソトレチノインを処方する医師と患者のmandatory registries[強制登録]の必要可否も審議。
※[審議結果]16:8で現行のSMARTを一歩進めたsingle risk management proposal を採択。Roche及び後発品メーカーに適用される。
Accutane (isotretinoin)
  2003.11.21 Inamed, Medicis Hyaluronic Acid Dermal Fillers - General & Plastic Surgery Devices Panel Hyaluronic Acid
  2003.9.25 Myopia Treatment Trial Design[近視]
※Novartis Ophthalmicsの報告[2003.1]によると同社はValley Forge Pharmaceuticalsのライセンス契約に基づきpirenzepineの近視への適応で臨床開発中で、P2では12カ月で50%の改善効果があった。
※Visudyne[Novartis and QLT]は2001.8にFDA承認されているが、病理学的近視と眼ヒストプラスマ症によるclassic型choroidal neovascularization (CNV=脈絡膜新生血管形成)を適応としている。
 
  2003.9.10 Photocure ASA Metvix (Methylaminolevulinate) For Basal Cell Carcinoma[BCC=基底細胞癌(発育が遅く浸潤性だが通常転移しない腫瘍)]
※Metvix PDTはまたactinic keratoses[AK=紫外線角膜炎]の適応症で2001.9申請、FDAはAKについては2002.9 "approvable"と判断している。
※会議記録 | 資料Briefing Information | 議事録Transcript
Metvix (methylaminolevulinate)
1171 2003.9.9 Genentech/Xoma's Raptiva For Psoriasis
※申請Dec. 23, 2002;27% (98/368)で75%以上の改善率
※Psoriasis(乾癬)用薬としてはBiogen's Amevive(alefacept)が初承認の生物製剤。3つのtumor necrosis factor inhibitorsが乾癬適応開発中(Amgen’s Enbrel (etanercept) has a pending sBLA, Centocor’s Remicade (infliximab) is in Phase III and Abbot’s Humira (adalimumab) is in Phase II.)。
※審議結果として"chronic stable moderate-to-severe plaque psoriasis"の適応で承認勧告。
(efalizumab)
  2003.03.17 ISTA Vitrase For Vitreous Hemorrhage
※硝子体出血の適応で2002.1.3にRolling NDA開始。
ISTA Pharmaceutical社は米アラガン社に日・メキシコを除く全世界ライセンス。また糖尿病性網膜症の適応でP2
※Brief Information;効果は8/4で否認。
(ovine
hyaluronidase)
  2002.11.5 Acne Drug Development Draft Guidance - Day 2  
  2002.11.4 Acne Drug Development Draft Guidance - Day 1  
1154 2002.05.23 Biogen Amevive For Chronic Plaque Psoriasis(慢性尋常性乾癬)
※乾癬の発症機序は不明ながら、活性化T細胞や種々のサイトカインの関与が考えられており、本剤が認可されれば最初の活性化T細胞の修飾作用をもつ薬剤となる。 諮問委は有効性・安全性の点で承認勧告。 但し対象は中等度から重症患者で他の治療法の効果がない場合。 注射剤。
(alefacept)
1147 2002.04.22 Schering-Plough Claritin Rx-to-OTC Switch Applications (loratadine)
  2000.11.17 Topical Dermatologic Bioequivalence Draft Guidance  
1102 2000.11.16 Fujisawa Protopic Advisory Committee Review  
1139 2000.09.19 Accutane For Severe Recalcitrant Nodular Acne (isotretinoin)
1139 2000.09.18 Accutane For Severe Recalcitrant Nodular Acne (isotretinoin)
  2000.06.30 J&J Miconazole Committee Review  
  2000.06.29 Schering-Plough Lotrisone Committee Review (clotrimazole+
betamethasone
dipropionate)
  2000.06.29 Dermex Pharmaceuticals Dermex II Committee Review  
ML 開催日 議題 備考
     
  2011.09.09 The committees will discuss the benefits and risks of long-term bisphosphonate use for the treatment and prevention of osteoporosis (thinning and weakening of bones that increases the chance of having a broken bone) in light of the emergence of the safety concerns of osteonecrosis of the jaw (jawbone death) and atypical femur fractures (unusual broken thigh bone) that may be associated with the long-term use of bisphosphonates. Bisphosphonates for the treatment and prevention of osteoporosis include: FOSAMAX (alendronate sodium) tablets and solution and FOSAMAX PLUS D (alendronate sodium/cholecalciferol) tablets, Merck & Co., Inc.; ACTONEL (risedronate sodium) tablets, ATELVIA (risedronate sodium) delayed release tablets, and ACTONEL WITH CALCIUM (Copackaged) (risedronate sodium with calcium carbonate) tablets, Warner Chilcott, LLC; BONIVA (ibandronate sodium) tablets and injection, Roche Therapeutics, Inc.; RECLAST (zoledronic acid) injection, Novartis Pharmaceuticals Corporation; and the generic equivalents for these products, if any.※合同Reproductive Health Drugs AC and the Drug Safety and Risk Management AC 
※資料Briefing Information | [Slides] | 議事要旨Minutes | 議事録Transcripts【審議結果】Y=,N=0,保留=
bisphosphonate
  2011.07.20 The committees will discuss the drug development program of an investigational gastroenterology drug※合同Gastrointestinal Drugs AC and the Drug Safety and Risk Management AC 
※資料| 議事録Transcripts【審議結果】Y=,N=0,保留=
 
  2011.05.02 On May 2, 2011, the committees will discuss safety considerations of ultrasound contrast agents (materials intended to improve the clarity of ultrasound imaging), particularly related to new information and developments since the prior Advisory Committee meeting on the same topic on June 24, 2008. The discussion will include the results of required postmarketing safety studies and data from postmarketing surveillance. Specific drugs to be discussed include: (1) New drug application (NDA) 21-064, perflutren lipid microsphere injectable suspension, Lantheus Medical Imaging, Inc.; (2) NDA 20-899, perflutren protein-type A microspheres injectable suspension, GE Healthcare; and (3) the investigational new drug (IND) application for sulfur hexafluoride microbubble injection, Bracco Diagnostics, Inc. Perflutren lipid microsphere injectable suspension and perflutren protein-type A microspheres injectable suspension are indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border (improve the clarity of imaging of specific areas of the left lower side of the heart).※合同Cardiovascular and Renal Drugs AC and the Drug Safety and Risk Management AC 
※資料Briefing Information | [Slides] | 議事要旨Minutes | 議事録Transcripts【審議結果】Y=,N=0,保留=
ultrasound contrast agents
  2010.11.03 The committees will discuss a number of safety concerns with intravenous administration of the anti-seizure drugs phenytoin and fosphenytoin, including the condition known as Purple Glove Syndrome (PGS), and recommend what regulatory actions, if any, are necessary to diminish the risks.※合同Peripheral and Central Nervous System Drugs AC and the Drug Safety and Risk Management AC 
※資料Briefing Information | [Slides] | 議事要旨Minutes【審議結果】Y=,N=0,保留=
phenytoin and fosphenytoin
  2010.10.21-22 The committee will discuss considerations for the design of postmarketing studies for new drug application (NDA) 22-272 , OxyContin (oxycodone hydrochloride controlled-release) Tablets, Purdue Pharma, Inc. and NDA 22-321 Embeda (morphine sulfate extended-release with sequestered naltrexone hydrochloride) Capsules, Alpharma Pharmaceuticals, LLC and King Pharmaceuticals Research & Development, Inc., approved for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The postmarketing studies are intended to be epidemiological or observational studies that will assess the known serious risks of these products and whether product-specific properties which are intended to deter misuse and abuse actually result in a decrease in the risks of misuse and abuse, and their consequences: addiction, overdose, and death.※合同Anesthetic and Life Support Drugs AC and the Drug Safety and Risk Management AC 
※資料Briefing Information | [Slides] | 議事要旨Minutes | 議事録Transcripts1 - Transcripts2【審議結果】Y=,N=0,保留=
OxyContin/Embeda
  2010.09.14 The committee will discuss the abuse potential of the drug dextromethorphan and the public health benefits and risks of dextromethorphan use as a cough suppressant in prescription and nonprescription drug products 
※資料Briefing Information | [Slides] | 議事要旨Minutes | 議事録Transcripts【審議結果】Y=,N=0,保留=
dextromethorphan
  2010.08.10 (NDA) 22-531, sodium oxybate, 375 milligrams per milliliter (mg/ml) oral solution, sponsored by Jazz Pharmaceuticals, with a proposed indication for the treatment of fibromyalgia for patients 18 years of age and older. The safety and efficacy findings for sodium oxybate in the fibromyalgia population and the proposed Risk Evaluation and Mitigation Strategy (REMS) for this product will be discussed.※合同Arthritis AC and the Drug Safety and Risk Management AC 
※資料Briefing Information | [Slides] | 議事要旨Minutes | 議事録Transcripts【審議結果】Y=,N=0,保留=
sodium oxybate
  2010.07.22-23 Risk Evaluation and Mitigation Strategies (REMS) for extended-release and long-acting opioid analgesics※合同Anesthetic and Life Support Drugs AC and the Drug Safety and Risk Management AC 
※資料Briefing Information | [Slides] | 議事要旨Minutes | 議事録Transcripts1 - Transcripts2【審議結果】Y=,N=0,保留=
opioid analgesics
  2010.07.13-14 On both days, the committees will focus primarily on the cardiovascular safety of AVANDIA (rosiglitazone maleate) Tablets, GlaxoSmithKline, a drug approved for blood glucose control in adults with type 2 diabetes mellitus. Data specific to rosiglitazone to be presented will include results from the Rosiglitazone Evaluated for Cardiac Outcome and Regulation of Glycemia in Diabetes (RECORD) Trial, observational data, health claims data, and a meta-analysis of controlled clinical trials. In addition, the FDA will present its meta-analysis of several trials of ACTOS (pioglitazone hydrochloride) Tablets, Takeda Pharmaceuticals North America, Inc., another thiazolidinedione for the same indication, in response to public documents comparing the safety of rosiglitazone to pioglitazone based on different meta-analyses performed on each of these two drugs.※合同Endocrinologic and Metabolic Drugs AC and the Drug Safety and Risk Management AC 
※資料Briefing Information | [Slides] | 議事要旨Minutes | 議事録Transcripts1 - Transcripts2【審議結果】Y=,N=0,保留=
AVANDIA (rosiglitazone maleate)/ACTOS (pioglitazone)
  2010.05.12 (NDA) 22-478, naproxcinod 375 milligram capsule, sponsored by NicOx S.A., a non-steroidal anti-inflammatory drug (NSAID) product indicated for the treatment of the signs and symptoms of osteoarthritis.※合同Arthritis AC and the Drug Safety and Risk Management AC 
※資料Briefing Information | [Slides] | 議事要旨Minutes | 議事録Transcripts【審議結果】Y=,N=0,保留=
naproxcinod
  2010.04.22 (NDA) 22-451 ACUROX (oxycodone HCl and niacin) Tablets, Acura Pharmaceuticals, Inc., for the proposed indication of relief of moderate to severe pain where the use of an immediate-release, orally administered, opioid analgesic tablet is appropriate, and the results of studies evaluating the addition of niacin, added for the purpose of reducing the misuse of oxycodone.※合同Anesthetic and Life Support Drugs AC and the Drug Safety and Risk Management AC 
※資料Briefing Information | [Slides] | 議事要旨Minutes | 議事録Transcripts【審議結果】Y=,N=0,保留=
ACUROX (oxycodone HCl and niacin) Tablets
  2010.03.10-11 The Committees will discuss the design of medical research studies (known as “clinical trial design”) to evaluate serious asthma outcomes (such as hospitalizations, a procedure using a breathing tube known as intubation, or death) with the use of the class of asthma medications known as long acting beta-2 adrenergic agonists in the treatment of asthma in adults, adolescents, and children.※合同Pulmonary-Allergy Drugs AC and the Drug Safety and Risk Management AC 
※資料Briefing Information | [Slides] | 議事要旨Minutes | 議事録Transcripts1 - Transcripts2【審議結果】Y=,N=0,保留=
asthma
  2009.12.08 The committees will discuss safety considerations related to FDA approved gadolinium-based contrast agents used with magnetic resonance imaging (MRI) scans. An MRI is a medical imaging technique that does not require x-rays. These scans outline the internal body structures such as organs and other soft tissues. Contrast agents are substances injected into the body before MRI scans, helping doctors to better see and interpret MRI findings. FDA approved gadolinium-based contrast agents include: gadobenate dimeglumine (MULTIHANCE), gadodiamide (OMNISCAN), gadopentetate dimeglumine (MAGNEVIST), gadoteridol (PROHANCE), gadoversetamide (OPTIMARK), gadoxetate disodium (EOVIST), and gadofosveset (ABLAVAR, previously known as VASOVIST). 
※資料Briefing Information | [Slides] | 議事要旨Minutes | 議事録Transcripts【審議結果】Y=,N=0,保留=
gadolinium-based contrast agents
  2009.09.24 NDA22-272, OxyContin (oxycodone hydrochloride controlled-release) Tablets, Purdue Pharma L.P., and its safety for the proposed indication of management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. The controlled-release characteristics of this formulation are purportedly less easily defeated than other approved formulations of controlled-release oxycodone 
※資料Briefing Information | 議事要旨Minutes 【審議結果】
OxyContin
1370 2009.09.23 (NDA) 21-217, EXALGO (hydromorphone HCl), Neuromed, Inc., and its safety for the proposed indication of treatment of moderate-to-severe pain in opioid tolerant patients 
※資料Briefing Information | [Slides] | 議事要旨Minutes 【審議結果】投票はなく、REMSが要求
hydromorphone HCl
1316 2009.06.29-30 discussion is how to address the public health problem of liver injury related to the use of acetaminophen in both over-the-counter (OTC) and prescription (Rx) products. FDA recognizes that acetaminophen is an important drug used to treat pain and fever in both settings and is not seeking to remove it from the market. The risk of developing liver injury to the individual patient who uses the drug according to directions is very low. However, acetaminophen containing products are used extensively making the absolute number of liver injury cases a public health concern. 
※資料Briefing Information | [Slides1] - [Slides2]| 議事要旨Minutes 【審議結果】[Q1:acetaminophenの最大1日投与量(4g)を引き下げるべきか?]最優先Y=11,Y=10,N=16 [Q2:成人最大1回量を650mgに制限すべきか?]最優先Y=12,Y=12,N=13  [Q3:1日投与量を引下げる場合、現在の非処方箋を要処方箋に切り替えるべきか?]最優先Y=8,Y=18,N=11 [Q4:包装サイズを制限すべきか?]最優先Y=2,Y=15,N=20  [Q5:配合剤を除外すべきか?]最優先Y=2,Y=11,N=14  [Q6:単一濃度のacetaminophen内服液の発売を推奨するか?]最優先Y=19,Y=17,N=1  [Q7:要処方薬acetaminophen配合剤を排除すべきか?]最優先Y=10,Y=10,N=17  [Q8:要処方薬acetaminophen配合剤販売が継続した場合、“unit-of-use”包装を推奨すべきか?]最優先Y=5,Y=22,N=10  [Q9:要処方薬acetaminophen配合剤にFDA黒枠警告を要求すべきか?]最優先Y=25,Y=11,N=1 
Acetaminophen
  2009.01.30 the safety and efficacy of propoxyphene and propoxyphene-combination products for the treatment of mild to moderate acute pain
※資料Briefing Information | [Slides] | 議事要旨Minutes 【審議結果】
propoxyphene
  2008.12.10-11 the benefit risk assessment of long acting beta-2 adrenergic agonists for the treatment of asthma in adults and children 
※資料Briefing Information | [Slides(1)] - [Slides(2)] | 議事要旨Minutes 【審議結果】
 
1334 2008.11.14 (NDA) 22-321, EMBEDA (morphine sulfate extended-release with sequestered naltrexone hydrochloride) Capsules, Alpharma Pharmaceuticals L.L.C., and its safety for the proposed indication of management of moderate to severe chronic pain. The naltrexone component of this formulation is intended to mitigate abuse of the product when attempts are made to defeat the controlled-release properties of the formulation. 
※資料Briefing Information | [Slides] | 議事要旨Minutes | 議事録Transcripts1 - Transcripts2【審議結果】Y=,N=0,保留=
EMBEDA (morphine sulfate/naltrexone)
  2008.11.13 NDA22-324, REMOXY XRT (oxycodone hydrochloride controlled-release) Capsules, Pain Therapeutics Inc., and its safety for the proposed indication of management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. The controlled-release characteristics of this formulation are purportedly less easily defeated than other formulations of controlled-release oxycodone. 
※資料Briefing Information | [Slides] | 議事要旨Minutes 【審議結果】
oxycodone
  2008.05.06 (sNDA) 21-947/s-005, FENTORA (fentanyl buccal tablet), Cephalon, Inc., and its safety for the proposed indication of breakthrough pain in opioid tolerant non-cancer patients with chronic pain. 
※| [Slides] | 議事要旨Minutes 【審議結果】
fentanyl buccal
  2008.05.05 new drug application (NDA) 22-272, OXYCONTIN (oxycodone hydrochloride controlled-release) Tablets, Purdue Pharma L.P., and its safety for the proposed indication of management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. The sustained-release characteristics of this formulation are purportedly less easily defeated than other formulations of OXYCONTIN 
※資料Briefing Information | [Slides] | 議事要旨Minutes 【審議結果】
OXYCONTIN
  2008.02.01 the efficacy and safety of new drug application (NDA) 22-054, INJECTAFER (ferric carboxymaltose injection), Luitpold Pharmaceuticals Incorporated, used for the treatment of iron deficiency anemia in patients with postpartum hemorrhage or heavy uterine bleeding. 
※資料Briefing Information | [Slides] | 議事要旨Minutes 【審議結果】
INJECTAFER (ferric carboxymaltose injection)
  2007.09.12 [Cardiovascular and Renal Drugs AC/Drug Safety and Risk Management AC合同] aprotinin injection (TRASYLOL, Bayer Pharmaceuticals)の安全性問題 aprotinin
1260 2007.09.11 [Cardiovascular and Renal Drugs AC/Drug Safety and Risk Management AC合同] erythropoeisis-stimulating agents (ARANESP, Amgen, Inc., EPOGEN, Amgen, Inc., and PROCRIT, Amgen, Inc.)の安全性問題 epoetin
  2007.07.31 [Gastrointestinal Drugs AC/Drug Safety and Risk Management AC合同] TYSABRI (natalizumab)のクローン病の追加適応症
※資料Briefing Information ※FDAとBIOGEN IDEC, Inc社との間で本剤の有効性と安全性に関して合意に達しなかった。 なお本剤の肝障害が問題となっている。
 
1265 2007.07.30 [Endocrinologic and Metabolic Drugs AC/Drug Safety and Risk Management AC合同] thiazolidinediones特にrosiglitazoneの心血管および血栓リスク
※資料Briefing Information | 議事録Minutest
※【審議結果】1)Avandiaが心血管リスクを増加させるか? Y=20/N=3 2)Avandiaのrisk-benefitの観点から米国での販売を継続すべきか? Y=22/N=1 
rosiglitazone
  2006.12.14 the overall benefit to risk considerations for KETEK (telithromycin)※Anti-Infective Drugs Advisory Committee合同 (telithromycin)
  2006.12.14 the overall benefit to risk considerations for KETEK (telithromycin)※Anti-Infective Drugs Advisory Committee合同
※会議記録 | 資料Briefing Information | 議事録Minutes
※[審議結果] 1)販売を継続すべきか? Community-acquired pneumonia(Y=16/N=3), Community-acquired pneumonia(Y=2/N=17) , Acute bacterial sinusitis(Y=3/N=17)以下略
(telithromycin)
  2006.02.10 FDA Actions On COX-2 Selective NSAIDs; Risk Management Program For Isotretinoin Products
※会議記録 | 資料Briefing Information - [COX2阻害剤]Analysis and Recommendations for Agency Action Regarding Non-steroidal Anti-Inflammatory Drugs and Cardiovascular Risk[2006.4.6]  - [Isotretinoin]Tab 10: Isotretinoin Update(oIsotretinoin Update: iPLEDGE oIsotretinoin Teratogenicity Risk Management Program) 
※ | 議事録Transcript
COX2阻害剤
(isotretinoin)
1205 2006.02.09 Attention Deficit/Hyperactivity Disorder Drug Cardiovascular Adverse Events
※興奮剤系ADHD治療薬のアンフェタミン剤による突然死等を契機に調査がはじまりその結果を踏まえて対応を決める。(Shire’s Adderall, Adderall XR, and Dextrostat; GlaxoSmithKline’s Dexedrine and Dexedrine Spansules), methylphenidate (J&J’s Concerta, Novartis’ Ritalin, Ritalin SR, and Ritalin LA; Alliant’s Methylin and Methylin ER; UCB/Celltech’s Metadate ER and Metadate CD), methamphetamine (Ovation’s Desoxyn) and dexmethylphenidate (Novartis’ Focalin)
※非致命的な重篤に心血管系副作用発生率は処方箋100万件当たりで小児でmethylphenidate 0.18とamphetamine 0.53、成人で各0.74 and 1.79、 突然死発生率=小児0.16 for methylphenidate versus 0.36 for those taking amphetamine. 成人では0.07 for methylphenidate and 0.53 for amphetamine. ※[Brief Information]
※[審議結果] 1)患者及び親用medication guideの作成に賛否15:0棄権1 2)ラベルに黒枠警告追加に賛否8:7棄権1
 
  2005.05.18 FDA's Risk Assessment Program For Marketed Drugs - Day 1  
  2005.05.19 FDA's Risk Assessment Program For Marketed Drugs - Day 2
※会議記録 | 資料Briefing Information | 議事録Transcript 5/17 - Transcript 5/19
※関連ガイダンスが審議された。 1)FDA Guidance for Industry: Premarketing Risk Assessment, dated March, 2005 2)FDA Guidance for Industry: Good Pharmacovigilance Practices and Pharmcoepidemiologic Assessment, dated March, 2005 3)FDA Reviewer Guidance: Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review, dated February, 2005 4)FDA Preliminary Concept Paper (Draft 4) “Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs”, June 10, 2004
 
  2005.02.16 Merck Vioxx/COX-2 Inhibitor Safety Review - Day 1
※Arthritis Drugs and Drug Safety & Risk Management Committees合同
※COX-2阻害剤の消化器安全性および心管系副作用を含めたbenefit-risk profileを検討する。 これはVioxxの市場回収に端を発し、今回の会議でPfizer社のCelebrex (celecoxib), Bextra (valdecoxib)およびPfizerの治験薬prodrug parecoxibの今後が決定される。 FDAは、2004.12.23にCOX-2阻害剤に関する警告を発令、"The caution leaves open the possibility for patients to use Pfizer’s Celebrex and Bextra as first-line therapies"
※[審議]Pfizer社は心管系副作用はVioxxに特有のものでCelebrex , Bextra などCOX-2阻害剤全体のものではないとの主張を展開した。 これに対し委員Garret FitzGerald (University of Pennsylvania)は、両剤とも現在策定中の新しいStandardで再評価すべきで、使用制限を厳しくし、特に60才以上には配慮すべきとした。
 
  2005.02.17 Merck Vioxx/COX-2 Inhibitor Safety Review - Day 2
※[審議]心管系副作用はVioxxに特有のものではなく、COX-2阻害剤全体のものと諮問委は結論。しかし用量や成分間の差はある。
 
  2005.02.18 Merck Vioxx/COX-2 Inhibitor Safety Review - Day 3
※[審議結果]1)Vioxx (rofecoxib) のrisk-benefit総体として、販売を支持するか? 17:15で支持派が優勢。 2)Bextra (valdecoxib)は販売を継続すべきか? 17:13:保留2 3)Celebrex (celecoxib) は販売を継続すべきか? 31:1
※3剤とも黒枠警告表示は義務づけられる。 メルク社はAPPROVe試験結果によりVioxx販売中止を決めたが、再販売を検討しており、その可能性が出てきた。しかしVioxxは2nd/3rd-lineでの使用となり、用量も従来の25mg/50mgから12.5mgに制限される。
 
  2004.07.12 Allergan Tazoral For Moderate To Severe Psoriasis
※Dermatologic & Ophthalmic and Drug Safety & Risk Management Committees合同
※[審議結果]本剤の強い催奇形性のため、リスク管理プログラムの研究が要請された。 リスク管理プログラムおよび安全問題に関する不確実性のため、棄権4,9-3で効果・安全性バランスは否定された。 
Tazoral(tazarotene)
  2004.05.05 GSK Lotronex Risk Management Program; LDPE Vial Medication Errors
※IBD治療薬ロトロネックスはFDA/GSK間で虚血性大腸炎(49症例報告)と重篤な便秘(21症例報告)に関する問題の合意が成立せず、市販9カ月後の2000.11に市場回収された。 その後2002.11制限プログラム付きで再販売を開始。 2002.11.20-2004.2.6の間に患者1万人の報告文書3.4万件が収集された。 同じ期間にFDAは虚血性大腸炎(8例)と重篤な便秘(5例)を受け取っている。
※[審査結果]安全性と効果を更に確認するため、現在のリスク管理プログラムを継続すべきである。
Lotronex (alosetron)
  2004.02.27 Accutane Risk Management - Day 2
※会議記録 | 資料Briefing Information | 議事録Transcript 2/26 & Transcript 2/27
Accutane (isotretinoin)
  2004.02.26 Accutane Risk Management - Day 1
※ロシュ社で2年前に採用された'SMART' program (System to Manage Accutane Related Teratogenicity)に関して審議の一年後レビュー結果が"minimal to no improvement."であるとして、FDAは妊娠予防を含めて、修正したisotretinoin risk management programs (RMPs)iPLEDGEを求めた。 このRMPs結果について審議する。 ここでは、イソトレチノインを処方する医師と患者のmandatory registries[強制登録]の必要可否も審議。
※[審議結果]16:8で現行のSMARTを一歩進めたsingle risk management proposal を採択。Roche及び後発品メーカーに適用される。
Accutane (isotretinoin)
  2003.12.04 Screening Methods For Sound-Alike/Look-Alike Drug Names
※Brief Information※2003.9.18から台風により延期
※[審議結果]医療過誤を避けるために医薬品商品名を決める目的で提出されたFDA命名ガイドライン案は、まだ不十分
 
  2003.10.15 Anti-Counterfeiting Drug Initiative Public Meeting  
  2003.09.23 Direct-To-Consumer Promotion Public Meeting - Day 2  
  2003.09.22 Direct-To-Consumer Promotion Public Meeting - Day 1  
  2003.09.18 Medical Errors Related To Labeling & Packaging
※Brief Information※台風により延期
 
  2003.07.31 Usefulness Of Consumer Rx Drug Information - Public Meeting  
  2003.06.26 Minimizing Medical Errors - Evaluating The Drug Naming Process  
  2003.04.09 Science Board to the Food & Drug Administration  
  2002.07.17 Consumer Rx Drug Information  
  2002.05.22 FDA Risk Management "Toolkit" Public Hearing  
1081 2002.04.23 GSK Lotronex Risk Management Subcommittee (Alosetron HC1)
  1999.04.20 Alcohol Use Disorder Drug Trial Design  
ML 開催日 議題 備考
     
  2016.  
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[]Y=,N=,保留=
 
1484 2016.06.28 The committee will discuss supplemental new drug application (sNDA) 204629 for empagliflozin (JARDIANCE) tablets and sNDA 206111 for empagliflozin and metformin hydrochloride (SYNJARDY) tablets. Both sNDAs are sponsored by Boehringer Ingelheim Pharmaceuticals, Inc., for the proposed additional indication in adult patients with type 2 diabetes mellitus and high cardiovascular risk to reduce the risk of all-cause mortality by reducing the incidence of cardiovascular death and to reduce the risk of cardiovascular death or hospitalization for heart failure. 
※資料Brief Information | Slides | 議事要旨Minutes |※【審議結果】[血糖管理を改善するempagliflozinが心管系リスクを増加しない]Y=23,N=0,保留=0 [empagliflozinが心管系死を低減する]Y=12,N=11,保留=0
empagliflozin
SYNJARDY
  2016.05.25 The committee will discuss the safety and efficacy of new drug application (NDA) 208583 for insulin degludec and liraglutide injection, submitted by Novo Nordisk Inc., for the proposed indication: adjunct to diet and exercise to improve glycemic control in the treatment of adults with type 2 diabetes mellitus. 
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[]Y=,N=,保留=
insulin degludec and liraglutide
  2016.05.24 The committee will discuss the safety and efficacy of new drug applications (NDAs) 208673 for insulin glargine and lixisenatide injection, a fixed ratio drug product consisting of insulin and a GLP-1 receptor agonist, and 208471 for lixisenatide injection, a GLP-1 receptor agonist, submitted by Sanofi Aventis c/o Sanofi U.S. Services Inc., proposed for the treatment of adults with type 2 diabetes mellitus. 
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[]Y=,N=,保留=
insulin glargine and lixisenatide
  2015.12.14 The committee will discuss the results of the IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT). IMPROVE-IT was a clinical trial that studied the effect of ezetimibe/simvastatin compared with simvastatin on the occurrence of cardiovascular events in patients with recent acute coronary syndrome. The results from this trial have been submitted to support supplemental new drug applications 21445/S-038 and 21687/S-054, ZETIA (ezetimibe) and VYTORIN (ezetimibe/simvastatin) tablets, respectively, by MSD International GmbH. The proposed indication for ZETIA (in combination with a statin) and VYTORIN is to reduce the risk of cardiovascular events in patients with coronary heart disease. 
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[]Y=,N=,保留=
Vytorin
1479 2015.06.10 The committee will discuss the safety and efficacy of biologics license application (BLA) 125522, proposed trade name REPATHA (established name: Evolocumab) for injection, submitted by Amgen Inc., as adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (ApoB), non-high-density lipoprotein cholesterol (non-HDL-C), TC/HDL-C, ApoB/ApoA1, very low-density lipoprotein cholesterol, triglyceride, and lipoprotein A, and to increase HDL-C and ApoA1, in adults with hyperlipidemia or mixed dyslipidemia, either in combination with a statin or statin with other lipid-lowering therapies (e.g., ezetimibe), or alone, or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or alone or in combination with other lipid-lowering therapies in patients for whom a statin is not considered clinically appropriate. In addition, the committee will discuss the safety and efficacy of evolocumab to reduce LDL-C, TC, ApoB, and non-HDL-C, in combination with other lipid-lowering therapies (e.g. statins, LDL apheresis) in patients at least 12 years of age with homozygous familial hypercholesterolemia. 
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[ LDL-C低下でベネフィットがリスクを上回るか?]Y=11,N=4,保留=0 [ホモ接合性家族性高コレステロール血症患者でLDL-C低下でベネフィットがリスクを上回るか?]Y=15,N=0,保留=0
Evolocumab
1475 2015.06.09 The committee will discuss the safety and efficacy of biologics license application 125559, proposed trade name PRALUENT (established name: Alirocumab) for injection, submitted by Sanofi Aventis, U.S., as an adjunct to diet, for long-term treatment of adult patients with primary hypercholesterolemia (non-familial and heterozygous familial) or mixed dyslipidemia including patients with type 2 diabetes mellitus, to reduce low-density lipoprotein cholesterol, total cholesterol, non-high-density lipoprotein cholesterol, apolipoprotein B, tryglyceride, and lipoprotein A, and to increase high-density lipoprotein cholesterol and apolipoprotein A-1 either in combination with a statin or as monotherapy including in patients who cannot tolerate statins. 
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[ベネフィットがリスクを上回るか?]Y=13,N=3,保留=0
Alirocumab
  2015.04.14 During the morning session, the committee will discuss the results of the cardiovascular outcomes trial (CVOT), Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus, for new drug application (NDA) 22350, Onglyza (saxagliptin) and NDA 200678, Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets manufactured/marketed by AstraZeneca AB. 
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR)試験結果を考慮して、Saxagliptinの心管系リスクが受容可能と考えるか?]Y=13,N=1,保留=1 [安全性対応策]A(添付文書変更不要)=0,B(安全性情報追加)=14,C(安全性情報追加と流通制限)=0,D(市場回収)=1
Saxagliptin
  2015.04.14 During the afternoon session, the committee will discuss the results of the CVOT, Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care, for NDA 22271, Nesina (alogliptin); NDA 022426, Oseni (alogliptin and pioglitazone); and NDA 203414, Kazano (alogliptin and metformin) tablets marketed by Takeda Pharmaceutical U.S.A., Inc. 
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care (EXAMINE) 試験結果を考慮して、alogliptinの心管系リスクが受容可能と考えるか?]Y=16,N=0,保留=0 [安全性対応策]A(添付文書変更不要)=3,B(安全性情報追加)=13,C(安全性情報追加と流通制限)=0,D(市場回収)=0
Alogliptin
  2015.01.12 (NDA) 022517, proposed trade name NOCDURNA (established name: desmopressin), orally disintegrating sublingual tablets submitted by Ferring Pharmaceuticals, Inc. The proposed indication is treatment of nocturia due to nocturnal polyuria in adults who awaken two or more times each night to void. 
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[]Y=,N=,保留=
desmopressin
1470 2014.09.12 (BLA) 125511, proposed trade name NATPARA (established name: Recombinant Human Parathyroid Hormone (rDNA) or (rhPTH[1-84]), submitted by NPS Pharmaceuticals, Inc., for the proposed indication of replacement for endogenous parathyroid hormone (1-84) for the long-term treatment of hypoparathyroidism. 
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[有効性と安全性の観点からrisk-benefit上、承認を支持するか?]Y=8,N=5,保留=0
rhPTH[1-84]
1471 2014.09.11 (NDA) 206321, liraglutide for injection, sponsored by Novo Nordisk, Inc. The proposed indication for liraglutide is as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kilograms per square meter (kg/m2) or greater, or with an initial BMI of 27 kg/m2 or greater in the presence of at least one weight-related comorbidity. 
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[体重減少に関するベネフィット/リスクで承認すべきか?]Y=14,N=1,保留=0
liraglutide
1463 2014.04.01 (NDA) 22-472, proposed trade name AFREZZA (TECHNOSPHERE Insulin Inhalation System), 3 unit and 6 unit cartridges for oral inhalation, manufactured by MannKind Corporation. The proposed indication (use) for this application is to improve glycemic control in adult patients with type 1 or type 2 diabetes mellitus. 
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[成人1型糖尿病に有効性・安全性を示したか?]Y=13,N=1,保留=0,棄権=1 [成人2型糖尿病に有効性・安全性を示したか?]Y=14,N=0,保留=0,棄権=1
AFREZZA (TECHNOSPHERE Insulin Inhalation System)
1436 2013.12.12 (NDA) 202293, dapagliflozin tablet, submitted by Bristol-Myers Squibb. Dapagliflozin is a sodium-glucose co-transporter 2 inhibitor developed as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[心管リスクは許容可?]Y=10,N=4,保留=0 [ベネフィットは?]Y=13,N=1,保留=0
dapagliflozin
1460 2013.12.11 (BLA) 125390, metreleptin for injection, sponsored by Amylin Pharmaceuticals, LLC, a wholly owned subsidiary of Bristol Myers Squibb. The proposed indication for metreleptin is the treatment of metabolic disorders associated with lipodystrophy, including diabetes mellitus and/or hypertriglyceridemia (elevated triglyceride levels in the blood) in pediatric and adult patients with inherited or acquired lipodystrophy. (Lipodystrophies are rare medical conditions of abnormal loss of the body's fatty tissues.)  
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[全身性脂肪異栄養症治療に対し、リスクを上回るベネフィットを実証したか?]Y=11,N=1,保留=0 [部分脂肪異栄養症を伴う、高血糖症・糖尿病を含む代謝異常の治療に対し、リスクを上回るベネフィットを実証したか?]Y=2,N=10,保留=0
metreleptin
  2013.11.19 (BLA) 125460, for Vimizim (elosulfase alfa), manufactured by BioMarin Pharmaceutical, Inc., for the treatment of Mucopolysaccharidosis Type IVA (Morquio A syndrome). Morquio A syndrome is a rare congenital disorder caused by the absence or malfunctioning of an enzyme involved in an important metabolic pathway, leading to problems with bone development, growth and movement. 
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[]Y=,N=,保留=
Vimizim (elosulfase alfa)
1415 2013.10.16 NDA 202057/S-005, Vascepa (icosapent ethyl) Capsules, submitted by Amarin Pharmaceuticals Ireland Ltd. Vascepa is currently approved as monotherapy for the treatment of severe hypertriglyceridemia. This supplemental application proposes concomitant use with an inhibitor of HMG-CoA reductase (statin) to reduce triglycerides (TG), non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (Apo B), low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC) and very-low-density lipoprotein cholesterol (VLDL-C) in adults with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent. 
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[]Y=,N=,保留=
Vascepa (icosapent ethyl)
  2013.06.5-6 discuss the results of an independent readjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial, for new drug application (NDA) 21071, AVANDIA (rosiglitazone maleate) tablets. Rosiglitazone is a thiazolidinedione, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. AVANDIA is manufactured by GlaxoSmithKline. 
※資料Brief Information | Slides |※【審議結果】[]Y=,N=,保留=
Rosiglitazone
1416 2013.01.10 (NDA) 204042, canagliflozin tablets, proposed trade name INVOKANA, submitted by Janssen Research and Development, LLC. Canagliflozin is a member of the sodium-glucose co-transporter 2 (SGLT2) inhibitors, and was developed as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[CVイベントのリスク比が1.8未満の基準をクリアしているという結論に懸念があるか?]Y=8,N=7,保留=0 [有効性と安全性について十分か?]Y=10,N=5,保留=0
canagliflozin
  2012.11.08 discuss the safety and efficacy of new drug applications (NDAs) 203313, insulin degludec/insulin aspart [rDNA origin] injection and 203314, insulin degludec [rDNA origin] injection, manufactured by Novo Nordisk Inc. The proposed indication (use) for these applications is for the treatment of Type 1 and Type 2 diabetes mellitus. 
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[]Y=,N=,保留=
insulin degludec/insulin aspart
1416 2012.11.07 discuss the safety and efficacy of a new drug application (NDA) 200677, pasireotide injection (proposed trade name SIGNIFOR) for subcutaneous administration, submitted by Novartis Pharmaceuticals Corporation. Pasireotide is an analog (a chemical compound that resembles another compound in structure) of somatostatin. The proposed indication (use) for pasireotide injection is the treatment of patients with Cushing’s disease who require medical intervention (Cushing’s disease is a rare medical condition of excessive cortisol secretion that is secondary to a tumor located in the pituitary gland). 
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[有効性と安全性について十分か?]Y=10,N=0,保留=0
pasireotide
1413 2012.10.18 discuss the safety and efficacy of new drug application (NDA) 203568, mipomersen injection, sponsored by Genzyme Corporation as an adjunct to maximally tolerated lipid-lowering medications and diet to reduce low-density lipoprotein (LDL) cholesterol, apolipoprotein B, total cholesterol, nonhigh density lipoproteincholesterol and lipoprotein (a) in patients with homozygous familial hypercholesterolemia. 
※資料Brief Information | Slides |議事要旨Minutes | 議事録Trascripts※【審議結果】[有効性・安全性データは十分か?]Y=9,N=6,保留=0
mipomersen
1413 2012.10.17 discuss the safety and efficacy of new drug application (NDA) 203858, lomitapide tablets, sponsored by Aegerion Pharmaceuticals, Inc. The proposed indication (use) is as an adjunct to a low-fat diet and other lipid-lowering drugs with or without low-density lipoprotein (LDL) apheresis to reduce LDL cholesterol, total cholesterol, apolipoprotein B, and triglycerides in patients with homozygous familial hypercholesterolemia 
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[有効性・安全性データは十分か?]Y=13,N=2,保留=0
lomitapide
1398 2012.05.10 discuss the safety and efficacy of new drug application (NDA) 22-529 (lorcaserin hydrochloride) tablets, manufactured by Arena Pharmaceuticals, Inc., as an adjunct to diet and exercise for weight management in patients with a body mass index (BMI) equal to or greater than 30 kilograms (kg) per square meter or a BMI equal to or greater than 27 kg per square meter if accompanied by weight-related co-morbidities. 
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[ベネフィット]Y=18,N=4,保留=1
lorcaserin
  2012.03.28-29 discuss the role of cardiovascular assessment in the preapproval and postapproval settings for drugs and biologics developed for the treatment of obesity 
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts1 - Trascripts2※【審議結果】[肥満薬に対してCVリスクを超えることをルール化すべきか?]Y=17,N=6,保留=0
Anti-obesity
1398 2012.02.22 discuss the safety and efficacy of new drug application (NDA) 22-580, proposed trade name QNEXA (phentermine/topiramate) Controlled-Release Capsules, manufactured by VIVUS, Inc., as an adjunct to diet and exercise for weight management in patients with a body mass index (BMI) equal to or greater than 30 kilograms (kg) per square meter or a BMI equal to or greater than 27 kg per square meter if accompanied by weight-related co-morbidities. 
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[総合的リスク/ベネフィット評価による認否]Y=20,N=2,保留=0
QNEXA (phentermine/topiramate)
1381 2011.11.02 s-NDA21-687 and 21-445, VYTORIN (ezetimibe/simvastatin) and ZETIA (ezetimibe) tablets, respectively, MSP (Merck/Schering-Plough) Singapore Company, LLC. Simvastatin lowers lipids (fats that circulate in the bloodstream, including cholesterol) by inhibiting 3-hydroxy-3-methyl-glutaryl-CoA reductase, which is an enzyme involved in producing lipids in the body, and ezetimibe lowers lipids by inhibiting the absorption of cholesterol from the intestine. The proposed indication (use) of ZETIA in combination with simvastatin or VYTORIN is to reduce major cardiovascular events in patients with chronic kidney disease based on the results of the Study of Heart and Renal Protection (SHARP). SHARP was a clinical trial that studied the effect of VYTORIN compared with placebo on the occurrence of major cardiovascular events in patients with chronic kidney disease who did not have a history of myocardial infarction or coronary revascularization (heart bypass surgery or opening heart vessels with a balloon or stents). The primary outcome of major cardiovascular events was defined as the first occurrence of either nonfatal myocardial infarction, cardiac death, stroke, or coronary or noncoronary revascularization (including nontraumatic amputation). The primary analysis demonstrated that assignment to VYTORIN significantly reduced the relative risk of a major cardiovascular event by 16% compared to placebo. 
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[Vytorinの心管系イベント予防の有効性と安全性〜透析前慢性腎不全患者]Y16,N0 [Vytorinの心管系イベント予防の有効性と安全性〜透析を受ける末期腎不全患者]Y6,N10
VYTORIN (ezetimibe/simvastatin) and ZETIA (ezetimibe)
  2011.07.19 The committee will discuss new drug application (NDA) 202293 dapagliflozin, manufactured by Bristol-Myers Squibb and AstraZeneca. Dapagliflozin is the first drug in the class of sodium-glucose co-transporter 2 (SGLT2) inhibitors, developed as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】
dapagliflozin
  2011.05.19 The committee will discuss the findings of the Action to Control Cardiovascular Risk in Diabetes-Lipid (ACCORD Lipid) trial as they relate to the efficacy and safety of the approved new drug application (NDA) 22224, TRILIPIX (fenofibric acid) delayed release capsules, manufactured by Abbott Laboratories. TRILIPIX (fenofibric acid), an active form of fenofibrate, is indicated for use in combination with a “statin”, to lower high levels of serum triglycerides and raise low levels of high-density lipoprotein cholesterol in patients with mixed dyslipidemia and coronary heart disease (CHD) or CHD risk equivalent who are on optimal statin therapy to achieve their low-density lipoprotein cholesterol goal. 
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】
TRILIPIX (fenofibric acid)
1455 2010.12.07 The committee will discuss the safety and efficacy of new drug application (NDA) 20-0063, proposed tradename CONTRAVE (naltrexone HCl/bupropion HCl) extended-release tablets, manufactured by Orexigen Therapeutics, Inc., for the treatment of obesity and weight management, including weight loss and maintenance of weight loss in patients with an initial body mass index (BMI) of equal to or greater than 30 kilograms (kg) per square meter, or a BMI equal to or greater than 27 kg per square meter with one or more risk factors (e.g. diabetes, dyslipidemia, or hypertension). The BMI is a measure of body weight (mass) based on a person’s weight and height, and is a widely-used tool for doctors in assessing optimum weights for a patient. 
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[臨床試験は十分か?血圧と脈拍への効果、心管系副作用を考慮して]承認前に必要=8,承認後で良い=11,保留=1 [ベネフィット/リスク評価]Y=13,N=7,保留=0
CONTRAVE (naltrexone HCl/bupropion HCl)
  2010.09.15 The committee will discuss the results of the Sibutramine Cardiovascular Outcomes Trial (SCOUT) (M01-392), for new drug application (NDA) 20-632, MERIDIA (sibutramine hydrochloride monohydrate) Capsules, sponsored by Abbott Laboratories, for treatment of obesity. The SCOUT study was a randomized, double-blind, placebo-controlled trial, which is a kind of clinical trial designed to provide data with strong measures of accuracy and reliability. The SCOUT trial evaluated the potential benefits of weight loss with MERIDIA on major cardiovascular (heart and blood circulation) adverse events. The preliminary results of the SCOUT trial indicated that clinical trial participants who received MERIDIA instead of placebo (no active drug) had a higher incidence of major cardiovascular adverse events that was statistically significant. 
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[販売継続を許すか?]Y=8,N=8,保留=0
MERIDIA (sibutramine)
1398 2010.09.16 The committee will discuss the safety and efficacy of new drug application (NDA) 22-529, with the proposed trade name LORQESS (lorcaserin hydrochloride) Tablets, sponsored by Arena Pharmaceuticals, Inc., as an adjunct to diet and exercise for weight management in patients with a body mass index (BMI) of equal to or greater than 30 kilograms (kg) per square meter, or a BMI equal to or greater than 27 kg per square meter if accompanied by weight-related co-morbidities (which include, for example: high blood pressure, heart disease, or diabetes). The BMI is a measure of body weight (mass) based on a person’s weight and height, and is a widely-used tool for doctors in assessing optimum weights for a patient. 
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[ベネフィット/リスク評価]Y=5,N=9,保留=0
LORQESS (lorcaserin)
1398 2010.07.15 (NDA) 22-580, proposed tradename, QNEXA (phentermine/topiramate) Controlled Release Capsules by VIVUS, Inc., as an adjunct to diet and exercise for weight management in patients with a body mass index of 30 kilograms (kg) per square meter, or a body mass index equal to or greater than 27 kg per square meter if accompanied by weight-related co-morbidities. 
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[ベネフィット/リスク評価]Y=6,N=10,保留=
QNEXA (phentermine/topiramate)
  2010.07.13-14 The cardiovascular safety of AVANDIA (rosiglitazone maleate) Tablets, GlaxoSmithKline, a drug approved for blood glucose control in adults with type 2 diabetes mellitus. Data specific to rosiglitazone to be presented will include results from the Rosiglitazone Evaluated for Cardiac Outcome and Regulation of Glycemia in Diabetes (RECORD) Trial, observational data, health claims data, and a meta-analysis of controlled clinical trials. In addition, the FDA will present its meta-analysis of several trials of ACTOS (pioglitazone hydrochloride) Tablets, Takeda Pharmaceuticals North America, Inc., another thiazolidinedione for the same indication, in response to public documents comparing the safety of rosiglitazone to pioglitazone based on different meta-analyses performed on each of these two drugs.★ the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee合同 AVANDIA (rosiglitazone maleate)
ACTOS (pioglitazone)
1363 2010.05.27 (NDA) 22-505, EGRIFTA (tesamorelin acetate), sterile lyophilized powder for injection, by Theratechnologies, Inc. EGRIFTA is an analogue (a chemical compound that resembles another compound in structure) of growth hormone releasing hormone (GHRH). The proposed indication (use) for EGRIFTA in this application is to induce and maintain a reduction of excess visceral abdominal fat in human immunodeficiency virus (HIV)-infected patients with lipodystrophy (a condition in which abnormal deposits of fat are seen partly as a result of using certain drugs to treat HIV disease). 
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】Y=16/N=0で承認勧告
EGRIFTA (tesamorelin acetate)
1363 2010.02.14 (NDA) 22-505, for EGRIFTA (tesamorelin acetate) sterile lyophilized powder for injection, by Theratechnologies, Inc. EGRIFTA is an analogue (a chemical compound that resembles another compound in structure) of growth hormone releasing hormone (GHRH). The proposed indication (use) for EGRIFTA in this application is to induce and maintain a reduction of excess visceral abdominal fat in human immunodeficiency virus (HIV)-infected patients with lipodystrophy (a condition in which abnormal deposits of fat are seen partly as a result of using certain drugs to treat HIV disease). ※【キャンセル】 EGRIFTA (tesamorelin acetate)
  2010.01.12 (NDA) 21-348, ZAVESCA (miglustat), 100 milligram (mg) capsules, by Actelion Pharmaceuticals, Ltd., proposed for the treatment of progressive neurological manifestations (symptoms related to the nervous system) in patients with Niemann-Pick Disease (type C).  
※資料Brief Information | 議事録Trascripts※【審議結果】
ZAVESCA (miglustat) 
  2010.01.13 NDA 22-562, CARBAGLU (carglumic acid), 200 mg tablets, by Orphan Europe SARL, proposed for the treatment of hyperammonemia (elevated levels of ammonia in the blood) in patients with N acetyl glutamate synthetase (NAGS) deficiency, an inherited disorder that causes ammonia to accumulate in the blood. 
※資料Brief Information |議事録Trascripts※【審議結果】
CARBAGLU (carglumic acid)
  2009.12.15 (sNDA) 21-366, CRESTOR (rosuvastatin calcium) tablets, AstraZeneca Pharmaceuticals.今回審議する追加適応は「primary prevention of cardiovascular disease based on the results of JUPITER」 
※資料Brief Information | Slides | 議事録Trascripts※【審議結果】
rosuvastatin
1324 2009.04.01 NDA 22-350, saxagliptin tablets, Bristol-Myers Squibb
※資料Brief Information | Slides | 議事録Transcript | 議事要旨Minutes※【論点】1.saxagliptinの心血管イベント発生率が低いかを検証 2.糖尿病薬の心血管リスク評価の新ガイダンスに関連して“SMQ MACE” and “Custom MACE” endpoints 3.saxagliptinの24日間の短期試験で血糖管理不十分な患者は長期試験でのエントリーから除外されているが、その点の試験デザインを論議 4.心血管リスク評価に複数の統計を使用しているが、その妥当性。※【審議結果】同剤の心血管リスクは許容範囲との見解を示したと発表した。また、心血管プロファイルを確認するための市販後臨床試験の実施を満場一致で推奨した。  [1.同剤の心血管リスクは許容範囲か?]Yes=10,No=2,保留=0 [2.心血管リスク評価のCustom MACE endpointは市販後調査が不要な程十分か?]Yes=0,No=12,保留=0 
saxagliptin
1335 2009.04.02 NDA 22-341, liraglutide injection, Novo Nordisk, I
※資料Brief Information | Slides | 議事録Transcript | 議事要旨Minutes※【審議結果】[循環器系安全性エビデンスに関し、リスク比95%信頼区間およびオッズ比が1.8以下か?]Yes=8,No=5,保留=0 [動物の甲状腺C細胞癌が人体に該当しないとのデータが十分か?]Yes=1,No=12,保留=0 [甲状腺C細胞癌のリスク/ベネフィット上でliraglutideの販売を認めるべきか?]Yes=6,No=6,保留=1 [乳頭癌(甲状腺癌の一種)のリスク/ベネフィット上でliraglutideの販売を認めるべきか?]Yes=12,No=0,保留=1  
liraglutide
  2008.10.21 ポンペ病治療薬MYOZYME (alglucosidase alfa), Genzyme Corp.,
※資料Brief Information | 議事要旨Minutes
MYOZYME (alglucosidase alfa)
  2008.07.1-2 2型糖尿病薬の心管系安全性 
※資料Brief Information | 議事要旨Minutes
※【審議結果】[Q.市販薬および治験薬のP2/3の長期CV臨床試験か要求されるべきか?]Y14=,N=2,保留=0
糖尿病薬
  2007.12.13 MEVACOR (lovastatin)のOTC
※資料Brief Information | 議事要旨Final Minutes
※【審議結果】[Q.FDAはOTC losvastatinを認可すべきか?]Y=2,N=10,保留=1
OTC losvastatin
1265 2007.07.30 Cardiovascular ischemic/thrombotic risks of the thiazolidinediones, with focus on rosiglitazone, as presented by FDA and GlaxoSmithKline.[合同the Drug Safety and Risk Management Advisory Committee]
※資料Brief Information
※【審議結果】1)Avandiaが心血管を増加させるか? Y=20/N=3 2)Avandiaのrisk-benefitの観点から米国での販売を継続すべきか? Y=22/N=1
rosiglitazone
  2007.06.13 ZIMULTI(R) (rimonabant) -- Sanofi-Aventis for the indication of smoking cessation
※資料Brief Information | 議事要旨Minutes 
ZIMULTI(R) (rimonabant)
  2006.10.4 Joint Advisory Committee meeting on levothyroxine sodium drug products
※[Briefing Information]levothyroxine sodiumの安定性の欠如が薬効の劣化や臨床上の問題をひきおこすのではないかという懸念から審議された。
levothyroxine sodium
  2006.1.23 GlaxoSmithKline Orlistat For OTC Use To Promote Weight Loss  
1239 2005.9.8 Pfizer Exubera Inhaled Insulin For Diabetes Mellitus(初の吸入型インスリンでI型・II型糖尿病の“intensive” control薬剤;)
※Brief Information【審査結果】I型糖尿病の有効性については8-1、II型糖尿病の効果は全員一致。I型糖尿病の臨床試験が十分な効果を示さないとするFDAの拒否は諮問委では否決された。FDAはPfizer's Study 107が皮下注インスリンに劣らないことを実証しているけれども、被験者の平均HbA1cが7%以下という基準(DCCT=the Diabetes Control and Complications Trialによる基準)を達成していないことを問題視しているのだ。 次に肺についての安全性に関して、賛成4対反対5。
Exubera
  2005.9.9 Bristol-Myers Squibb Pargluva (Muraglitazar) For Type II Diabetes Mellitus Pargluva
(Muraglitazar)
  2005.01.14 Merck/J&J Mevacor Rx-To-OTC Switch Day 2
※[審議結果]OTC Switchは否認。 Mevacor Dailyの商品名で販売予定だった20mg製剤のOTCは、20-3で否認。 否認理由は、患者による治療の自己選択が不可、そして長期使用・試験への対応不可。
Mevacor
  2005.01.13 Merck/J&J Mevacor Rx-To-OTC Switch Day 1 Mevacor
  2004.09.08 FDA Obesity Drug Development Draft Guidance
※FDAは、1996.9.24にコメント発表し、2004.1.26に “Guidance on the Clinical Evaluation of Weight Control Drugs”を発表。 FDAは抗肥満剤開発促進を目的として草稿を再発行しようとしている。 抗肥満剤の最大効果は6-12カ月に発現する。 従って承認前に、1年間の効果試験、2年間の安全性試験が必要とした。
※Brief Information
 
  2004.04.22 FDA Critical Path Initiative; Obesity Working Group Report - FDA Science Board(新薬開発を加速するための"Critical Path":市販抗肥満薬のCardiovascular endpoints等の比較)  
  2003.10.23 FDA Obesity Public Meeting
※肥満症Draft Guideline制定のため
 
  2003.10.7 Wyeth Prempro Second-Line Use For Post-Menopausal Osteoporosis
※WHI研究報告はPrempro .625 mg/2.5 mgが乳癌と心脈環系副作用のリスクを増大させるという衝撃的結果を提示した
※[審議結果]Premproの現在のラベルに表示されている適応「骨粗鬆症予防」は現状でok。 なお同製品は2003.1にラベル改訂し、"when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered."としている。
Prempro[Wyeth]
1167 2003.7.09 AstraZeneca Crestor For Hypercholesterolemia, Mixed Dyslipidemia
※腎機能モニタリングを条件に全員一致で承認勧告
※"approvable" letter 2002.5に対して、同社は2003.2.12にデータ提出(10mg,20mg,40mg)。2003.8中頃がUser Feeゴール。 80mgにはBaycol同様にrhabdomyolysis and renal impairmentのため開発中止
(rosuvastatin)
1169 2003.06.10 Lilly Humatrope For Non-Growth Hormone Deficiency Short Stature
※現在の承認適応は、(1)小児の成長ホルモン分泌不全性低身長症 (2)ターナー症候群 (3)成人の成長ホルモン分泌不全
※審議結果として小児の患者登録が要請される
somatropin
1165 2003.01.13 Genzyme Fabrazyme For Fabry Disease
※FDA Bfief Information→腎臓内GL-3脂質濃度低下に対する効果が臨床効果予測のsurrogate endpointとなる。
※代用エンドポイントsurrogate endpointは→EBMとコクラン用語
※EMEA承認Fabrazyme
(agalsidase beta) 
  2003.01.14 Transkaryotic Therapies Replagal For Fabry Disease
※FDA Brief Information| 2002.11 FDAはデータ不十分としたが..今回賛否半ば、やや否定的
(algalsidase alfa)
1168 2003.01.15 Genzyme/BioMarin Aldurazyme For MPS 1
※FDA Brief Information|Mucopolysaccharidosis I酵素欠乏症の女性患者に限定見込み
(laronidase)
  2002.11.21 Wyeth BMP-2 Collagen Sponge For TIbial Fractures※キャンセル  
  2002.09.25 Osteoporosis Therapy Trial Design  
1149 2001.07.27 Lilly Forteo For Osteoporosis (Teriparatide)
承認=26-Nov-02
1209 2001.07.26 Amylin Symlin Diabetes Treatment Review※Brief Information Symlin(pramlintide)
  2000.07.14 Pravachol OTC Switch For Cholesterol Reduction  
  2000.07.13 Mevacor OTC Switch For Cholesterol Reduction  
  2000.05.19 Rezulin Withdrawal From Type 2 Diabetes Market  
ML 開催日 議題 備考
   
1451 2013.12.09 the committees will discuss two biologics license applications (BLAs) for vedolizumab injection (proposed tradename Entyvio), submitted by Takeda Pharmaceuticals, USA Inc. . BLA 125476 proposes an indication for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, have lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα) antagonist. BLA 125507 proposes an indication for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to, have lost response to, or were intolerant to either conventional therapy or a TNFα antagonist.
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[クローン病への初期治療の有効性を実証したか?]Y=12,N=9,保留=0 [クローン病への維持療法の有効性を実証したか?]]Y=19,N=1,保留=1 [PMLリスクへの安全性は承認可能か?]Y=21,N=0,保留=0 [承認時免疫抑制剤の併用を制限すべきか?]Y=1,N=19,保留=1 [潰瘍性大腸炎でのベネフィットがリスクを上回り承認条件をつけるとしたら A=ステロイド、免疫抑制剤、TNFα拮抗剤の失敗した患者 B=免疫抑制剤またはNFα拮抗剤の失敗した患者 C=AでもBでもない患者]A=13,B=8,C=0 [クローン病でのベネフィットがリスクを上回り承認条件をつけるとしたら A=ステロイド、免疫抑制剤、TNFα拮抗剤の失敗した患者 B=免疫抑制剤またはNFα拮抗剤の失敗した患者 C=AでもBでもない患者]A=14,B=6,C=1 
vedolizumab
1414 2012.10.16 (NDA) 203441, with the proposed trade name GATTEX (teduglutide) for subcutaneous injection, by NPS Pharmaceuticals, Inc, for the proposed indication of treatment of adult patients with short bowel syndrome (SBS).
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[有効性]Y=12,N=0,保留=0 [REMS計画]Y=10,N=1,保留=1 [ベネフィット]Y=11,N=1,保留=0 
GATTEX (teduglutide)
  2012.08.28 (sBLA) 125057/232, for Humira (adalimumab), by Abbott Laboratories, for the proposed indication (use) for reducing signs and symptoms, and achieving clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[]Y=,N=,保留= 
Humira (adalimumab)
  2012.03.13 discuss and provide general advice on the appropriate target populations, objectives and designs of trials intended to evaluate products for the control of hyperbilirubinemia (increased levels of bilirubin in the body) in newborn infants
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[]Y=,N=,保留= 
 
  2011.11.17 The committee will provide recommendations to the Agency on the design and size of premarketing cardiovascular safety development programs necessary to support approval of products in the class of serotonin (5-hydroxytryptamine) receptor 4 (5HT4) agonists for the proposed indications of chronic idiopathic (of unknown cause) constipation (CIC), constipation predominant irritable bowel syndrome (IBS-C), gastroparesis, and gastroesophageal reflux disease that does not respond to a proton pump inhibitor.
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[5-HT4 agonistsの新薬では既存薬の参考データがあるから、独自の試験を緩和するか?]Y=14,N=8,保留=0 [5-HT4 agonistsの適応症は増加しているが、心血管の安全性試験をすべきか?]Y=9,N=11,保留=2 [5-HT4 agonistsに独自に心血管安全性試験を要求すべきか?]Y=4,N=17,保留=1 
5-HT4 agonists
  2011.11.16 The committee will discuss the design of clinical trials to evaluate the safety, efficacy and durability of response with repeat treatment cycles of XIFAXAN (rifaximin) by Salix Pharmaceuticals, Inc., for irritable bowel syndrome with diarrhea.
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[1A-IBS再発予防]Y=1,N=11,保留=0 [1B-IBS再発の急性短期的治療]Y=11,N=0,保留=1 [1C-IBSの治癒または長期的軽減]Y=6,N=6,保留=0 [この諮問委で提示された研究デザインはIBS再発の急性短期的治療に適当か?]Y=9,N=1,保留=2 [rifaximin 550mgを1日3回2週間は、再発防止に繰り返す必要があるか?]Y=11,N=1,保留=0 [抗生物質の慢性投薬に関して、IBS-D長期治療の対象を制限すべきか?]Y=2,N=8,保留=2 以下略
rifaximin
  2011.07.21 sBLA 103772/5301, REMICADE (infliximab), by Centocor Ortho Biotech Inc., in the treatment of pediatric patients with moderately to severely active ulcerative colitis
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[]Y=,N=,保留= 
infliximab
  2011.01.12 (NDA) 022486, for Solpura (liprotamase) Capsules, by Alnara Pharmaceuticals, for the proposed indication (use) in the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy (surgical removal of all or part of the pancreas), or other conditions that may impair or limit function of the pancreas. The pancreas is an organ involved, in part, in the digestion of food through the use of specialized proteins called enzymes. Exocrine pancreatic insufficiency is a decreased ability to digest food due to deficient enzyme production by the pancreas.
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[]Y=,N=,保留= 
Solpura (liprotamase)
  2010.11.05 to discuss results from clinical trials of proton pump inhibitors in gastroespohageal reflux disease (GERD) in patients less than one year of age, performed in response to a Pediatric Written Request under the Best Pharmaceuticals for Children Act (Nexium, esomeprazole by AstraZeneca LP; Prevacid, lansoprazole by Takeda Pharmaceuticals North America, Inc; Protonix, pantoprazole by Pfizer, Inc.) and Pediatric Research Equity Act (PREA) commitment (Prilosec, omeprazole by AstraZeneca LP). The pathophysiology (disease process) of GERD, its diagnosis and management, and issues related to the design of clinical trials in this age group will be considered.
※資料Brief Information | Slides | 議事要旨Minutes※【審議結果】[GERDの病態生理は生後1ヵ月〜1歳未満と成人と同じか?]Y=4,N=14,保留=3 [成人の症候性GERD治療に酸抑制薬を承認する場合、生後1ヵ月〜1歳未満新生児の試験も要求すべきか?]Y=19,N=1,保留=1
 
1376 2010.11.04 the adequacy of endoscopically documented gastric ulcers as an outcome measure to evaluate drugs intended to prevent gastrointestinal complications of nonsteroidal anti-inflammatory drugs (NSAIDs) including aspirin
※資料Brief Information | Slides | 議事要旨Minutes※【審議結果】[NSAIDSによる胃腸障害予防薬のプライマリイ・エンドポイントとして内視鏡診断による胃十二指腸は十分か?Products: Misoprostol, H2RAs (Histamine-2 Recepter Antagonist), PPIs (Proton Pump Inhibitor)]Y=8,N=4,保留=1 [NSAIDS製品開発に関してNSAIDSによる上部GI毒性の評価する場合、エンドポイントとして内視鏡診断による胃十二指腸は十分か?Products: NSAIDs]Y=4,N=8,保留=1
Duexis
1350 2010.02.23 the efficacy and safety of new drug application (NDA) 22-554 for XIFAXAN (rifaximin) Tablets 550 mg, manufactured by Salix Pharmaceuticals, for the indication (use) of maintenance of remission of hepatic encephalopathy, a condition in which severe liver disease contributes to an accumulation of toxic substances that impair brain function. This indication is for patients 18 years of age and older
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[有効性]Y=15,N=3,保留=0 [安全性]Y=12,N=6,保留=0 [用量と投与期間]Y=13,N=5,保留=0 [リスクベネフィット]Y=14,N=4,保留=0
XIFAXAN (rifaximin)
  2009.05.19 the safety and efficacy of (NDA) 21-761, Sanvar,(vapreotide acetate), by Debiovision, Inc., for the proposed indication as an adjunctive therapy to endoscopic intervention for the control of acute esophageal bleeding as a result of portal hypertension.
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[有効性]Y=1,N=13,保留=0 [強いリスクを上回るベネフィットはあるか?]Y=0,N=14,保留=0 
Sanvar,(vapreotide acetate)
  2008.01.23 the safety and efficacy of new drug application (NDA) 21-775, ENTEREG (alvimopan), Adolor Corp., for the proposed indication of acceleration of time to upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis.
※資料Brief Information | Slides | 議事要旨Minutes※【審議結果】[有効性]Y=13,N=0,保留=2 [Cardiovascular events]Y=8,N=6,保留=1 [全体的ベネフィット]Y=9,N=6,保留=0 [リスク管理プランは十分か?]Y=0,N=14,保留=1 
ENTEREG (alvimopan)
  2007.07.31 for Patients With Moderately to Severely Active Crohn's Disease
※資料Brief Information | Slides | 議事要旨Minutes※【審議結果】[安全性]Y=12,N=3,保留=2 ]Y=,N=,保留= []Y=,N=,保留= 
TYSABRI (natalizumab)
  2004.07.14 Novartis Zelnorm For Chronic Constipation
※[審議結果]10-3で承認勧告
Zelnorm (tegaserod maleate)
  2003.6.25 Serono Serostim For Short Bowel Syndrome(短腸症候群)
※小腸切除等に随伴する腸管からの吸収不全、吸収不良症候群であるSBS患者に対して本剤の2002.7 P3報告ではIVHによる栄養補給量の減少に成功している
※諮問委は追加データを要求
(somatotropin)
  2003.6.26 Axcan Photofrin For Barrett's Esophagus(バレット食道)
※Axcan社は本適応について2002.11.29 "approvable" letterを受け取っており、この要請に対して2年間のデータを提出したもの。本剤は既に食道癌に対する適応を取得している
※諮問委の評決は5-5。
(porfimer sodium
1162 2003.03.06 Merck Emend For Chemotherapy-Induced Nausea
※メーカーによるとZofran[GSK],Kytril[Roche]に代表される5-HT3拮抗剤はCINV=chemotherapy-induced nauseaの急性症状にしか有効でないのに対し、本剤は急性・遅延性双方に有効
同社はsubstance P neurokinin-1 receptor antagonistとして2002年2QにNDAファイル、2002.12にこのNDAが優先reviewを受けていることを発表
審査対象は本剤のfor use in combination with other anti-emetic agents for the "prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, including high-dose cisplatin."
※承認勧告された。
(aprepitant, MK-869)
1083
1129
2002.06.21 AstraZeneca/Proctor & Gamble Prilosec Rx-to-OTC Switch (omeprazole)
1081 2002.04.23 GSK Lotronex Risk Management Subcommittee (Alosetron HCl)
  2002.03.19 Colorectal Cancer Chemopreventive Agent Trial Design  
1083
1129
2000.10.20 AstraZeneca Prilosec Rx-to-OTC Switch (omeprazole)
1094 2000.10.19 Phenylpropanolamine (PPA) Safety In OTCs  
1081 2000.06.27 Lotronex Risk Management Of Post-Marketing Adverse Events (Alosetron HCl)
1139 2000.06.26 Novartis Zelmac Irritable Bowel Syndrome Review (Tegaserod Maleate)
ZELNORMとして承認24-July-2002
ML 開催日 議題 備考
   
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[]Y=,N=,保留=
 
  2016.09.14 The committee will discuss new drug application 208714, apaziquone for intravesical instillation, application submitted by Spectrum Pharmaceuticals, Inc. The proposed indication (use) for this product is for immediate intravesical instillation post-transurethral resection of bladder tumors in patients with non-muscle invasive bladder cancer. 
※資料Briefing Information | Slides | 議事要旨Minutes | | 【審議結果】[]Y=,N=,保留=
apaziquone
  2016.06.29 information will be presented for expert assessments related to exploring potential pediatric development plans for two products in various stages of development for adult cancer indications.   The discussion will also provide information to the Agency pertinent to the formulation of written requests for pediatric studies, if appropriate. The products under consideration are: (1) LOXO-101, presentation by Loxo Oncology, Inc., and (2) entrectinib, presentation by Ignyta, Inc.
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts1 - Transcripts2 | 【審議結果】[]Y=,N=,保留=
LOXO-101
entrectinib
  2016.06.28 Information will be presented for expert assessments related to exploring potential pediatric development plans for four products in various stages of development for adult cancer indications.   The discussion will also provide information to the Agency pertinent to the formulation of written requests for pediatric studies, if appropriate. The products under consideration are: (1) venetoclax, presentation by AbbVie, Inc. (2) tazemetostat, presentation by Epizyme, Inc., and (3) atezolizumab, presentation by Roche/Genentech. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts1 - Transcripts2 | 【審議結果】[]Y=,N=,保留=
tazemetostat
atezolizumab
  2016.04.12 The committee will discuss new drug application (NDA) 208542 rociletinib tablets, application submitted by Clovis Oncology, Inc. The proposed indication (use) for this product is for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation as detected by an FDA approved test. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[]Y=,N=,保留=
rociletinib
  2015.11.19 Information will be presented to gauge investigator interest in exploring potential pediatric development plans for two products in various stages of development for adult cancer indications. The subcommittee will consider and discuss issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of these products for pediatric use. The discussion will also provide information to the Agency pertinent to the formulation of written requests for pediatric studies, if appropriate. The products under consideration are: (1) ABT-414, sponsored by AbbVie, Inc., and (2) Lenvatinib, sponsored by Eisai, Inc. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts1 - Transcripts2 | 【審議結果】[]Y=,N=,保留=
 
  2015.07.09 BLA125547, necitumumab injection, application submitted by Eli Lilly and Company. The proposed indication (use) for this product is in combination with gemcitabine and cisplatin for first-line treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[]Y=,N=,保留=
necitumumab
1490 2015.01.07 (BLA) 125553 for EP2006, a proposed biosimilar to Amgen Inc.'s NEUPOGEN (filgrastim), submitted by Sandoz, Inc. The proposed indications (uses) for this product are: (1) To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever; (2) for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of adults with acute myeloid leukemia; (3) to reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by marrow transplantation; (4) for the mobilization of hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis; and (5) for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[Biosilimarとして認可されるべきか?]Y=14,N=0,保留=0
EP2006, biosimilar to NEUPOGEN (filgrastim)
  2014.11.16 Information will be presented to gauge investigator interest in exploring potential pediatric development plans for three products in various stages of development for adult cancer indications. The subcommittee will consider and discuss issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of these products for pediatric use. The discussion will also provide information to the Agency pertinent to the formulation of written requests for pediatric studies, if appropriate. The products under consideration are: (1) GANETESPIB, application submitted by Synta Pharmaceuticals Corp. (2) Etirinotecan, application submitted by Nektar Therapeutics, and (3) RO5503781, application submitted by Hoffmann-La Roche, Inc. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[]Y=,N=,保留=
 
1475 2014.11.06 (NDA) 205353, capsules, application submitted by Novartis Pharmaceuticals Corporation. The proposed indication (use) for this product is in combination with bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least 1 prior therapy. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[ベネフィットがリスクを上回るか?]Y=2,N=5,保留=0
panobinostat
  2014.11.06 NDA 206317, ferric pyrophosphate solution, for administration via hemodialysis dialysate, application submitted by Rockwell Medical, Inc. The proposed indications (uses) for this product are for the treatment of iron loss or iron deficiency to maintain hemoglobin in adult patients with hemodialysis-dependent stage 5 chronic kidney disease (CKD 5HD) and to reduce the prescribed dose of erythropoiesis stimulating agent (ESA) required to maintain desired hemoglobin levels. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[]Y=,N=,保留=
ferric pyrophosphate
1489 2014.06.25 (NDA) 206162, olaparib capsules, application submitted by AstraZeneca Pharmaceuticals LP. The proposed indication (use) for this product is as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed ovarian cancer (including fallopian tube or primary peritoneal) with germline BRCA mutation as detected by an FDA-approved test, who are in response (complete response or partial response) to platinum-based chemotherapy. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[承認すべきか?]Y=2,N=11,保留=2
olaparib
1470 2013.11.05 小児腫瘍副諮問委:The Pediatric Oncology subcommittee will consider and discuss issues relating to the development of each product for potential pediatric use and provide guidance to facilitate the formulation of Written Requests for pediatric studies, if appropriate. The two products under consideration are: (1) nivolumab, application submitted by Bristol Myers Squibb Co.; (2) MK-3475, application submitted by Merck Sharp and Dohme. 
※資料Briefing Information | Slides | 議事要旨Minutes |議事録Transcripts - Transcripts2 | 【審議結果】[]Y=,N=,保留=
nivolumab
MK-3475
LEE011
  2013.11.04 小児腫瘍副諮問委:Participants will discuss potential contexts of use for measuring both observable and unobservable concepts in specific pediatric cancer diagnoses across relevant age groups and defined disease stages using validated tools. No specific drug or biologic products or class of products will be discussed. 
※資料Briefing Information | Slides | 議事要旨Minutes | | 【審議結果】[]Y=,N=,保留=
 
1431 2013.09.12 (sBLA) 125409/51, with the trade name PERJETA (pertuzumab) injection, application submitted by Genentech, Inc. The proposed indication (use) for this product is in combination with trastuzumab and docetaxel for the neoadjuvant treatment of patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive, locally advanced, inflammatory, or early stage breast cancer (tumor greater than 2 cm in diameter) as part of a complete early breast cancer regimen containing either fluorouracil, epirubicin and cyclophosphamide (FEC) or carboplatin. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[リスク評価へのベネフィット]Y=13,N=0,保留=1
PERJETA (pertuzumab)
  2013.05.03 The committees will discuss the safety and efficacy of currently approved leukocyte growth factors (LGFs) as potential treatments for radiation-induced myelosuppression associated with a radiological/nuclear incident. (Myelosuppression is a reduction of blood cell production, which can be caused by radiation exposure.) Currently approved LGFs are licensed under biological license applications (BLAs): 103353, NEUPOGEN (filgrastim, Amgen, Inc.), 125031, NEULASTA (pegfilgrastim, Amgen, Inc.), 103362, LEUKINE (sargramostim, Genzyme, Inc.), and 125294, TBO-FILGRASTIM (tbo-filgrastim, Sicor Biotech, UAB). The National Institute of Allergy and Infectious Diseases (NIAID) has submitted efficacy data for filgrastim, based on treatment in an animal model of radiation-induced myelosuppression. Safety and other supportive information are currently described in the labeling for LGFs. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[骨髄抑制を惹起する放射線療法暴露に対しfilgrastim療法の臨床的ベネフィットを示すNIAID Studyを支持するか?]Y=17,N=1,保留=0
filgrastim
  2013.05.02 (NDA) 204408, with the established name tivozanib capsules, submitted by AVEO Pharmaceuticals, Inc. The proposed indication (use) for this product is for the treatment of advanced renal (kidney) cell carcinoma.
 NDA 201848, a drug/device combination product with the proposed trade name Melblez Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System), submitted by Delcath Systems, Inc. The proposed indication (use) for this product is for the treatment of patients with unresectable ocular melanoma that is metastatic to the liver
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】
tivozanib
melphalan
  2012.12.04 小児腫瘍副諮問委:pediatric provisions ;追加The subcommittee will consider and discuss issues relating to the development of each product for pediatric use and provide guidance to facilitate the formulation of written requests for pediatric studies, if appropriate. The four products under consideration are: (1) Trametinib, application submitted by GlaxoSmithKline, LLC; (2) TH-302, application submitted by Threshold Pharmaceuticals, Inc.; (3) volasertib (BI 6727), application submitted by Boehringer Ingelheim Pharmaceuticals, Inc.; and (4) blinatumomab (MT 103), application submitted by Amgen Inc. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】
 
  2012.07.25 The committee will discuss and provide general advice on the extent to which, if any, the pre-surgical identification of clear cell carcinoma of the kidney using an imaging test provides useful clinical information 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】
 
  2012.07.24 The committee will discuss the evaluation of radiographic review in randomized clinical trials using progression-free survival (PFS) as a primary endpoint in non-hematologic malignancies. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】
 
  2012.06.20 (NDA) 203213, with the established name semuloparin sodium injection, application submitted by sanofi-aventis U.S. LLC. The proposed indication (use) for this product is for the prophylaxis of venous thromboembolism (VTE) in patients receiving chemotherapy for locally advanced or metastatic pancreatic or lung cancer or for locally advanced or metastatic solid tumors with a VTE risk score ≧ 3. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[ベネフィット/リスクは承認に十分か?]Y=1,N=14,保留=1
semuloparin sodium
1406 2012.06.20 (NDA) 202714, with the proposed trade name Kyprolis (carfilzomib) for injection, application submitted by Onyx Pharmaceuticals, Inc. The proposed indication (use) for this product is for the treatment of patients with relapsed and refractory (recurring and/or not responsive to other treatments) multiple myeloma who have received at least 2 prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[ベネフィット/リスクは治療上十分か?]Y=11,N=0,保留=1
Kyprolis (carfilzomib)
  2012.03.21 (NDA) 202497, with the proposed trade name Marqibo (vincristine sulfate liposomes injection), application submitted by Talon Therapeutics, Incorporated. The proposed indication (use) for this product is for the treatment of adult patients with Philadelphia Chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more treatment lines of anti-leukemia therapy 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[ベネフィット/リスクは治療上十分か?]Y=7,N=4,保留=2
Marqibo (vincristine sulfate liposomes injection)
  2012.03.20 (sNDA) 022465/S-010, with the trade name Votrient (pazopanib hydrochloride) tablets, application submitted by Glaxo Wellcome Manufacturing Pte Ltd doing business as GlaxoSmithKline. The proposed indication (use) for this product is for the treatment of patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy. The phase 3 STS trial population excluded patients with adipocytic STS or gastrointestinal stromal tumors (GIST). 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[ベネフィット/リスクは治療上十分か?]Y=11,N=2,保留=0
Votrient (pazopanib hydrochloride)
  2012.03.20 (NDA) 022576, with the proposed trade name Taltorvic (ridaforolimus) tablets, application submitted by Merck Sharp & Dohme Corp. The proposed indication (use) for this product is for the treatment of adult and pediatric patients (aged 13 through 17 years with weight over 100 lb or 45.4 kg) with metastatic soft tissue sarcoma or bone sarcoma as a maintenance therapy for patients who have completed at least 4 cycles of chemotherapy without evidence of disease progression.  
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[ベネフィット/リスクは治療上十分か?]Y=1,N=13,保留=0
Taltorvic (ridaforolimus)
  2012.02.09 (sNDA) 21790/010 for DACOGEN (decitabine) for injection, application submitted by Eisai, Inc. The proposed indication (use) for this product is for the treatment of acute myelogenous leukemia (AML) in adults 65 years of age or older who are not considered candidates for induction chemotherapy, which is the standard first phase of treatment for AML 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[ベネフィット/リスクは治療上十分か?]Y=3,N=10,保留=1
DACOGEN (decitabine)
  2012.02.08 BLA125320/28 for XGEVA (denosumab) injection, application submitted by Amgen Inc. The proposed indication (use) for this product is for the treatment of men with castrate-resistant prostate cancer at high risk of developing bone metastases, or spread of cancer to the bones. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[ベネフィット/リスクは治療上十分か?]Y=1,N=12,保留=0
XGEVA (denosumab)
1392 2011.12.07 (NDA) 202324, with the proposed trade name INLYTA (axitinib) tablets, application submitted by Pfizer Inc. The proposed indication (use) for this product is for the treatment of patients with advanced renal cell carcinoma (RCC, kidney cancer). 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[ベネフィット/リスクから承認すべきか]Y=13,N=0,保留=0
INLYTA (axitinib)  
1392 2011.12.07 (NDA) 202799, with the established name peginesatide injection, application submitted by Affymax, Inc. The proposed indication (use) for this product is for the treatment of anemia associated with chronic renal failure (CRF) in adult patients on dialysis. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[ベネフィット/リスクから承認すべきか]Y=15,N=1,保留=1
peginesatide
  2011.11.02 The subcommittee will consider and discuss regulatory, academic and industry perspectives regarding the development of anticoagulant products (products to suppress clotting of blood) in children. Issues for discussion will include: identification of strategies to encourage and facilitate studies of anticoagulants in children that will result in informative pediatric labeling, appropriate endpoints for studies of anticoagulants in pediatric patients, and the role of pharmacokinetic/pharmacodynamic studies to support a pediatric indication for anticoagulants. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】
 
  2011.11.01 hear about pediatric development plans for four products that were either recently approved by the FDA or are in late stage development for an adult oncology indication. Based on the information presented, the subcommittee will consider and discuss issues relating to the development of each product for pediatric use and provide guidance to facilitate the formulation of Written Requests for pediatric studies, if appropriate. The four products under consideration are: (1) sodium thiosulfate, manufactured by Adherex Technologies, Inc., (2) vismodegib(GDC-0449), manufactured by Genentech, Inc. (3) pazopanib, manufactured by GlaxoSmithKline, and (4) medi-573, manufactured by MedImmune, LLC. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】
 
  2011.09.14 (NDA) 021825, with the proposed trade name FERRIPROX (deferiprone) film-coated tablets, application submitted by ApoPharma, Inc., represented by CATO Research Ltd. (authorized U.S. agent). The proposed indication (use) for this product is for the treatment of patients with transfusional iron overload (excess iron in the body related to blood transfusions), when current chelation therapy is inadequate. (Chelation therapy in these patients binds iron in a form that allows it to be eliminated from the body). 
※資料Briefing Information | Written Statements | Additional Written Statements | 【審議結果】
FERRIPROX (deferiprone)
  2011.09.14 the committee will consider the development of products for the treatment of patients with non-metastatic castration resistant prostate cancer (CRPC) who have a rising serum level of prostate-specific antigen (PSA) despite being on androgen deprivation therapy (ADT). There are no products currently approved for this indication. No specific products will be presented or discussed; rather, the committee will be asked to consider possible trial designs and suitable clinical endpoints to establish efficacy that would support a labeled indication for treatment of non-metastatic CRPC after PSA progression on ADT. Because ADT is an unproven therapy for this condition with serious long-term toxicity, the committee will be asked whether approval of a new therapy in conjunction with continued ADT would be appropriate for patients with non-metastatic CRPC. 
※資料Briefing Information | Written Statements | 【審議結果】
 
  2011.07.14 (BLA) 125388, with the proposed trade name ADCETRIS (brentuximab vedotin) for injection, submitted by Seattle Genetics, Inc. The proposed indication (use) for this product is for the treatment of relapsed or refractory (resistant to previous standard treatments) Hodgkin’s lymphoma (HL). The proposed indication (use) for this product is for the treatment of relapsed or refractory systemic anaplastic large cell lymphoma (ALCL).
※資料Briefing Information | Slides【審議結果】
ADCETRIS (brentuximab vedotin)
  2011.04.12 (sNDA) 022334/S-009, trade name Afinitor (everolimus) tablets, application submitted by Novartis Pharmaceuticals Corporation. The proposed indication (use) for this product is for the treatment of patients with advanced neuroendocrine tumors (NET) of gastrointestinal, lung, or pancreatic origin. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[everolimusが進行性膵神経内分泌腫瘍の治療についてリスクベネフィットは?]Y=10,N=0,保留=0
Afinitor (everolimus)  
  2011.04.12 sNDA 021938/S-013, trade name Sutent (sunitinib malate) capsules, application submitted by C.P. Pharmaceuticals International C.V., represented by Pfizer Inc. (authorized U.S. agent). The proposed indication (use) for this product is for the treatment of unresectable pancreatic neuroendocrine tumors (PNET). 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[sunitinibが膵神経内分泌腫瘍の治療についてリスクベネフィットは?]Y=8,N=2,保留=0
Sutent (sunitinib malate)
  2011.02.08 The committee will hear updates on new drug applications (NDAs) and biologics license applications (BLAs) approved under 21 CFR 314.500 and 601.40 (subpart H and subpart E, respectively, accelerated approval regulations) prior to January 1, 2009. These updates will provide information related to the status of phase IV clinical studies and to difficulties associated with completion of phase IV commitments. Phase IV studies are postmarketing studies to confirm clinical benefit of a drug after it receives accelerated approval.

Specifically, the committee will receive updates on the following products: (1) BLA 125084, trade name ERBITUX (cetuximab), application submitted by Imclone Systems Inc., used in combination with the anticancer agent irinotecan and indicated for the treatment of epidermal growth factor receptor (EGFR)-expressing colorectal cancer that has metastasized (spread beyond the colon or rectum) in patients for whom chemotherapy using irinotecan alone is ineffective or less effective; (2) supplemental BLA (sBLA) 125011/24, trade name BEXXAR (tositumomab and Iodine I 131 tositumomab), application submitted by SmithKline Beecham Corp. doing business as (d/b/a) GlaxoSmithKline, indicated for the treatment of patients with varieties of non-Hodgkin’s lymphoma known as CD20 antigen-expressing relapsed or refractory, low grade, follicular, or transformed non-Hodgkin's lymphoma, who have not received the drug Rituximab; (3) NDA 21-673, tradename CLOLAR (clofarabine) for intravenous infusion, application submitted by Genzyme Corp., indicated for the treatment of pediatric patients 1 to 21 years old with acute lymphoblastic leukemia (ALL) whose disease has not responded to or has relapsed following treatment with at least two prior chemotherapy regimens; (4) NDA 21-877, tradename ARRANON (nelarabine) Injection, application submitted by GlaxoSmithKline, indicated for the treatment of patients with types of leukemia or lymphoma known as T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens; (5) BLA 125147, tradename VECTIBIX (panitumumab), application submitted by Amgen Inc., indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens; and (6) sNDA 21-588/025, tradename GLEEVEC (imatinib mesylate) tablets, application submitted by Novartis Pharmaceuticals Corp., indicated for the adjuvant (additional) treatment of adult patients following complete gross resection (removal) of a form of cancer known as Kit (CD117) positive gastrointestinal stromal tumors (GIST). 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】

 
  2010.12.02 (BLA) 125377, with the proposed trade name Yervoy (ipilimumab), manufactured by Bristol-Myers Squibb Company with the proposed indication (use) for this product is for the treatment of advanced melanoma in patients who have received prior therapy →延期 Yervoy (ipilimumab)
1381 2010.12.02 (NDA) 022-405, with the proposed trade name Zictifa (vandetanib) Tablets, manufactured by iPR Pharmaceuticals, Inc., represented by AstraZeneca Pharmaceuticals LP (authorized US agent) with proposed indication (use) for this product is for the treatment of patients with unresectable (non-operable) locally advanced or metastatic medullary thyroid cancer 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[市販後調査で至適用量決定義務を要求するか?]Y=10,N=0,保留=0
vandetanib
  2010.12.01 (sNDAs) 021319/024, trade name AVODART (dutasteride) Soft Gelatin Capsules, manufactured by SmithKline Beecham Corporation d/b/a (doing business as) GlaxoSmithKline and 020180/034, trade name PROSCAR (finasteride) tablets, manufactured by Merck & Co., Inc. The proposed indication (use) for AVODART (dutasteride) is for reduction in the risk of prostate cancer in men at increased risk of developing the disease. The population at increased risk of prostate cancer includes men with an elevated serum prostate-specific antigen (PSA) or men otherwise determined to be at increased risk based on other associated risk factors such as age, race, and family history. There is no proposed expansion of the indication for PROSCAR (finasteride); however, in light of the Prostate Cancer Prevention Trial (PCPT) which demonstrated a statistically significant reduction in the 7-year period prevalence of prostate cancer with finasteride (PROSCAR) treatment, and which reported an imbalance in high Gleason grade prostate cancers (indicating more aggressive cancers) in the finasteride treatment arm vs. placebo, the efficacy and safety of both products for use in prostate cancer risk reduction will be examined. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[finasterideのリスクベネフィットは、直腸内診正常・PSAが3.0 ng/mL以下の55歳以下の男性で前立腺癌リスクを低減させるか?]Y=0,N=17,保留=1 [dutasterideのリスクベネフィットは、生検陰性でPSA上昇の場合、前立腺癌リスクを低減させるか?]Y=2,N=14,保留=2
PROSCAR (finasteride)
AVODART (dutasteride)
  2010.11.30 The subcommittee will consider and discuss issues relating to the development of each product for pediatric use and provide guidance to facilitate the formulation of Written Requests for pediatric studies, if appropriate. The four products under consideration are: (1) Crizotinib, manufactured by Pfizer, Inc.; (2) pralatrexate, manufactured by Allos Therapeutics, Inc.; (3) denosumab, manufactured by Amgen, Inc.; and (4) eribulin, manufactured by Eisai Inc. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】
 
  2010.7.20 (sBLAs) 125085/191 and 192 for AVASTIN (bevacizumab), manufactured by Genentech, Inc. The two proposed indications (uses) for this product are: (1) first-line treatment of a subgroup of women with metastatic breast cancer known as HER2-negative breast cancer, in combination with the chemotherapy drug docetaxel; and (2) first-line treatment of HER2-negative metastatic breast cancer in combination with one of two classes of chemotherapy drugs, known as taxanes and anthracyclines, or with the chemotherapy drug, capecitabine. In addition to the discussion of these two indications, the committee will also consider the impact of the submitted studies on the conversion from accelerated to regular approval of the indication for the treatment, in combination with the chemotherapy drug paclitaxel, of patients who have not received chemotherapy for their locally recurrent or metastatic HER2 negative breast cancer.
※資料Briefing Information | Slides | 議事要旨Minutes | 【審議結果】[Q1.-docetaxelにbevacizumab追加は転移性乳癌にrisk/benefit上良いか?]Y=0,N=13,保留=0 [Q2.-taxanes, anthracyclines or capecitabineにbevacizumab追加は転移性乳癌にrisk/benefit上良いか?]Y=1,N=12,保留=0 [Q3.-Q1.2.を考慮した上で、AVADO and RIBBON1の結果はbevacizumab+paclitaxelが転移性乳癌治療上臨床的ベネフィットを実証したか?]Y=0,N=13,保留=0 [Q4.-Avastinの転移性乳癌の適応症を除くべきか?]Y=12,N=1,保留=0 
AVASTIN (bevacizumab)
  2010.3.22 (NDA) 022-481, proposed trade name PIXUVRI (pixantrone dimaleate) injection, manufactured by Cell Therapeutics, Inc. The proposed indication (use) for this product is as a single agent treatment for patients with recurring or refractory (difficult to treat), aggressive non-Hodgkin’s lymphoma (NHL) who have received two or more prior lines of therapy.
※資料Briefing Information | Slides | 議事要旨Minutes | 【審議結果】[臨床試験は単一で未完了だが承認に十分か?]Y=0,N=9,保留=0 
PIXUVRI (pixantrone)
  2010.3.22 NDA 022-374, proposed trade name OMAPRO (omacetaxine mepesuccinate) for injection, manufactured by ChemGenex Pharmaceuticals. The proposed indication (use) for this product is for the treatment of adults with chronic myeloid leukemia (CML) bearing a genetic alteration known as the Bcr-Abl T315I mutation, and who have failed prior therapy with the drug imatinib.
※資料Briefing Information | Slides | 議事要旨Minutes | 【審議結果】[T315I mutationによる診断を義務づけ、omacetaxineの承認前の臨床試験に適用すべきか?]Y=7,N=1,保留=0 
OMAPRO (omacetaxine)
  2009.12.15 [Pediatric Oncology Subcommittee](1) FDA expectations regarding the development of pediatric formulations for cancer drugs, and (2) the development of dosing regimens in infants and toddlers with cancer.   
  2009.10.6 中止★(NDA) 021-825, proposed trade name FERRIPROX (deferiprone) film-coated tablets and oral solution, manufactured by ApoPharma Inc. The proposed indications (uses) for this product is as an iron chelating agent, which is a drug that binds with iron in the body and helps to make elimination of iron easier, reducing iron build-up. There are two specific proposed indications (uses) of FERRIPROX: (1) the treatment of iron overload, or build-up in patients with transfusion-dependent thalassemia, an inherited blood disorder that necessitates frequent transfusion of normal blood which can lead to iron build-up due to the iron content in the blood a patient receives; and (2) for the treatment of iron overload in patients with other transfusion-dependent anemias (other blood disorders that require frequent transfusions) for which the use of other iron chelating agents has been considered inappropriate.  FERRIPROX (deferiprone)
  2009.10.5 (1) (sBLA) 103949/5153.0, PEGINTRON (peginterferon alfa-2b) injection, manufactured by Schering Corporation. The proposed indication (use) for this product is as an adjuvant (additional) treatment for melanoma, a kind of skin cancer. The primary treatment for melanoma that is metastatic (has spread) to the lymph nodes is surgery to remove both the original cancer and lymph nodes surrounding the cancer. PEGINTRON’s proposed use is as a treatment in addition to, or as an “adjuvant,” to surgery;  
※資料Briefing Information | Slides | 議事要旨Minutes | 【審議結果】peginterferon alfa-2bのメラノーマ併用のベネフィット・リスク上の賛否は;Y=6,N=4,保留=0
PEGINTRON (peginterferon alfa-2b)
1337 2009.10.5 (2) (NDA) 022-465, proposed trade name VOTRIENT (pazopanib) tablets, manufactured by GlaxoSmithKline. The proposed indication (use) for this product is for the treatment of patients with advanced renal cell carcinoma, a form of kidney cancer. 
※資料Briefing Information | Slides | 議事要旨Minutes | 【審議結果】pazopanibのベネフィット・リスク上の賛否は;Y=10,N=0,保留=0
VOTRIENT(pazopanib)
1339 2009.9.2 (1) (NDA) 022-393, with the proposed trade name ISTODAX (romidepsin) Injection, manufactured by Gloucester Pharmaceuticals, Inc. The proposed indication (use) for this product is for the treatment of cutaneous T-cell lymphoma (CTCL), a form of cancer that arises in cells located in the skin, including relief of pruritus (itching), in patients who have received at least one prior systemic therapy 
※資料Briefing Information | 議事要旨Minutes | 【審議結果】romidepsinの有効性・安全性の実証:Y=10,N=0,保留=0/FDAはCTCL薬の承認をsingle-arm trialsを元におこなってきたが、将来randomized studiesとすべきか?:Y=7,N=3,保留=0
ISTODAX(romidepsin)
1342 2009.9.2 (2) NDA 022-468, with the proposed trade name FOLOTYN (pralatrexate) Injection, manufactured by Allos Therapeutics, Inc. with a proposed indication for the treatment of patients with relapsed or refractory (recurring and/or not responsive to other treatments) peripheral T-cell lymphoma (PTCL), a form of cancer that develops from cells in the body known as T-cells. 
※資料Briefing Information | 議事要旨Minutes | 【審議結果】賛否:Y=10,N=4,保留=0
FOLOTYN (pralatrexate)
  2009.9.1 (1) (sNDA) 021-673/S-009, CLOLAR (clofarabine) Injection for intravenous use, Genzyme Corporation, proposed indication for the treatment of previously untreated adults aged 60 years or older with acute myeloid leukemia with at least one unfavorable baseline prognostic factor 
※資料Briefing Information | 議事要旨Minutes | 【審議結果】Clolarの有効性・安全性の実証:Y=9,N=3,保留=0
CLOLAR(clofarabine)
  2009.9.1 (2) (NDA) 022-489, proposed trade name ONRIGIN (laromustine) Injection, Vion Pharmaceuticals, Inc., proposed indication for remission induction therapy for patients 60 years or older with de novo poor-risk acute myeloid leukemia (AML). 
※資料Briefing Information | 議事要旨Minutes | 【審議結果】laromustineの有効性・安全性の実証:Y=13,N=0,保留=0
ONRIGIN(laromustine)
1494 2009.7.15 1) (NDA) 022-447, proposed trade name YONDELIS (trabectedin) powder, for concentrate for solution for intravenous infusion, Centocor Ortho Biotech Products, L.P., proposed indication in combination with DOXCIL (doxorubicin HCl liposome injection), for the treatment of patients with relapsed ovarian cancer; 
※資料Briefing Information | Slides | 議事要旨Minutes | 【審議結果】trabectedinとDoxilの併用のベネフィット・リスク上の賛否は;Y=1,N=14,保留=0
YONDELIS (trabectedin)
  2009.7.15 (2) (sNDA) 050-718/S-039, DOXIL (doxorubicin HCl liposome injection), for intravenous infusion, Centocor Ortho Biotech Products, L.P., proposed indication in combination with docetaxel for the treatment of patients with locally advanced or metasatic breast cancer who have received prior anthracycline treatment.  
※資料Briefing Information | Slides | 議事要旨Minutes | 【審議結果】Doxilのdocetaxelへの追加併用のベネフィット・リスク上の賛否は;Y=0,N=13,保留=0
Doxil
1341 2009.5.29 (BLA) 125326, Arzerra (ofatumumab), GlaxoSmithKline, for the proposed indication of treatment of patients with chronic lymphocytic leukemia who have received prior therapy
※資料Briefing Information | Slides | 議事要旨Minutes | 【審議結果】[fludarabine and alemtuzumab難治性CLL患者への臨床的ベネフィットの有無]Y=10,N=3,保留=0
Arzerra (ofatumumab)
  2009.4.27 脳幹部神経膠腫 (diffuse pontine glioma)の子供で遺伝子発現パターンを評価するのに脳の生検標本を採取・使用することにかかわる科学的かつ倫理的な問題 
※資料Briefing Information | 【審議結果】
 
  2009.3.31 (sBLA) 125085/169, Avastin (bevacizumab), Genentech, Incorporated, proposed indication as single agent, for the treatment of previously treated glioblastoma multiforme. 
※資料Briefing Information | Slides | 議事要旨Minutes | 【審議結果】GBMは壊死や浮腫か不均一に発生しMRIによる測定に問題が多い。 さらにbevacizumabは血管透過性を中和、血液脳関門を安定させ、脳実質への液浸潤を減少させ、その結果浮腫を軽減し、ステロイドの必要量を減少させる。 MRIによる測定値がGBMの生存率のサロゲート・エンドポイントとなるかどうかは不明。 bevacizumabの2つの研究でMRIによる反応率は25.9%と19.6%、平均反応期間は4.2ヵ月と3.9ヵ月。 [再発性GBMの承認可否]Yes=10,No=0
Avastin (bevacizumab)
  2008.12.16 (BLA) 125084, trade name ERBITUX (cetuximab), ImClone Systems, Inc., and BLA 125147, trade name VECTIBIX (panitumumab), Amgen, Inc., in the context of K-ras as a predictive and/or prognostic biomarker in oncology drug development. 
※資料Briefing Information | 議事要旨Minutes | 【審議結果】
ERBITUX (cetuximab)
VECTIBIX (panitumumab)
1305 2008.05.30 (NDA) 022-291, proposed trade name PROMACTA (eltrombopag olamine), GlaxoSmithKline, proposed indication for the short-term treatment of previously-treated patients with chronic idiopathic thrombocytopenic purpura (ITP) to increase platelet counts and reduce or prevent bleeding.. 
※資料Briefing Information | 議事要旨Minutes | 【審議結果】In two randomized, "short term" clinical studies of adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP), a greater proportion of patients who received eltrombopag experienced a "platelet response" than patients who received a placebo (70% versus 11% in one study and 58% versus 16% in another study). To assess a treatment effect upon bleeding outcomes, the studies used a bleeding scoring system of unclear clinical meaningfulness. The studies signaled risks for serious hemorrhage following the discontinuation of eltrombopag as well as a risk for hepatotoxicity during the drug therapy. Clinical studies intended to thoroughly assess the safety and efficacy of long term eltrombopag use are ongoing and only limited, interim data are available.(投票結果)Yes=16全員一致で承認勧告
PROMACTA (eltrombopag olamine)
  2008.03.13 discuss the cumulative data, including recent study results, on the risks of erythropoeisis-stimulating agents when administered to patients with cancer. Agents to be discussed include ARANESP (darbepoetin alfa), EPOGEN (epoetin alfa), PROCRIT (epoetin alfa, Amgen, Inc.), and MIRCERA (methoxy polyethylene glycol-epoetin beta, Hoffman-La Roche Inc.). This is a followup to the May 10, 2007, Oncologic Drugs Advisory Committee Meeting. 
※資料Briefing Information | 議事要旨Minutes | 【審議結果】
epoetin
1305 2008.03.12 (1) Biologic license application (BLA) 125268, proposed trade name NPLATE (romiplostim), Amgen Inc., proposed indication for the treatment of thrombocytopenia in adults with chronic immune (idiopathic) thrombocytopenia purpura who are nonspelenectomized and have had an inadequate response or are intolerant to corticosteroids and/or immunoglobulins; or patients who are splenectomized and have an inadequate response to splenectomy, and (2)supplemental biologics license application (sBLA) 103949/5153, PEGINTRON (peginterferon alfa-2b), Schering Corp., proposed indication for adjuvant treatment of melanoma. 
※資料Briefing Information | 議事要旨Minutes | 【審議結果】(投票結果)Yes=10全員一致で承認勧告
NPLATE (romiplostim)
  2007.12.05 AVASTIN (Bevacizumab), Genentech, Inc - sBLA 125085/91(追加適応)in combination with paclitaxel, for the treatment of patients who have not received chemotherapy for their locally recurrent or metastatic, HER2 negative breast cancer.
※資料Briefing Information | 議事録Final Minutes
AVASTIN (Bevacizumab)
  2007.07.24 Evista (raloxifene Hcl) Eli Lilly & Co [Indication]: Invasive Breast Cancer Risk Reduction 
※資料Briefing Information
Evista (raloxifene Hcl)
  2007.06.27 [Pediatric Subcommittee ]1)the Best Pharmaceuticals for Children Act (BPCA)下で制癌剤の小児適応; 2)13-cis retinoic acidのneuroblastoma適応時BPCA下 
※資料Briefing Information | 議事要旨Minutes
 
  2007.05.09 NDA 022-092 mifamurtide (IDM Pharma, Inc)
NDA 022-062 orBec (oral beclamethasone diproprionate, BDP) (DOR BioPharma, Inc.) 
※資料Briefing Information | 議事要旨Minutes | 【審議結果】臨床試験INT 0133がmifamurtide (MTP-PE)の有効性を実証したか? Yes=2, No=12で否決。
mifamurtide
oral beclamethasone diproprionate
1260 2007.05.10 Safety of Erythropoiesis-Stimulating Agents (ESAs) in Oncology  
※資料Briefing Information | 議事要旨Minites
Erythropoetin
  2006.12.06 Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committeeで、小児脳腫瘍薬の治験のエンドポイントを検討する 
※Briefing Informationには「Guidance for Industry Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics」[pdf,287p]【審議結果】
 
  2006.09.06 (1) NDA 21-874, proposed trade name GENASENSE (oblimersen sodium) Injection, Genta, Inc., proposed indication for the treatment of patients with chronic lymphocytic leukemia in combination with fludarabine and cyclophosphamide;  
※Briefing Information【審議結果】再発性CLLの承認勧告は否決。 但し2006.10.29のNDA審査は実施予定※2006.12.15 FDAは申請を却下
Genasense (oblimersen sodium)
  2006.09.06 (2) NDA 020-287, FRAGMIN (dalteparin sodium), Pfizer, Inc., proposed indication for the extended treatment of symptomatic venous thromboembolism (VTE), proximal deep vein thrombosis, and/or pulmonary embolism to reduce the recurrence of VTE in patients with cancer. 
※Briefing Information
FRAGMIN (dalteparin sodium)
  2006.09.07 NDA 21-660, ABRAXANNE (paclitaxel protein-bound particles for injectible suspension) (albumin-bound), Abraxis Bioscience, Inc., including trial design issues for adjuvant treatment of node-positive breast cancer 
タンパク結合パクリタキセル小粒子懸濁注射液、アルブミン結合製剤であるアブラキサンは既に2005年1月にFDA承認され、その適応は「併用化学療法不応の転移性乳癌あるいは術後補助化学療法6ヶ月以内の再発例」。溶剤を含まないためパクリタキセル(タキソールに)に比べて神経毒性の副作用が軽減され、毒性が低いため今まで投与不能な全身状態不良患者や高齢者患者でも使用可能。アストラゼネカが米国で2006.7から5.5年の期間共同プロモーション契約を締結。 今回のNDA申請は、非リンパ節転移陽性の乳癌患者での併用療法。 ※Briefing Information【審議結果】資料が不十分として承認否決。
※大鵬薬品工業株式会社、日本国内におけるアブラキサンの開発・販売権を取得[2005.11.16]
ABRAXANE (paclitaxel protein-bound particles) (albumin-bound)
1252 2006.06.02 Bristol Sprycel For Resistant Leukemias※FDAとしては血液毒性を懸念して効果を減じない用量として70mgではなくて50mg BIDではどうかと提案、この件は6.28にレビューが実施される。 BMSではGleevec-resistant (Novartis' imatinib) CMLの適応認可を求めている。※Brief Information prycel (dasatinib)
1233 2006.03.14 Novartis Exjade (Deferasirox) Phase IV Commitments; Pediatric Clinical Studies For Methotrexate And Daunomycin; CDER Process For Handling Drug Shortages
※Exjade (Deferasirox)は1日1回投与の鉄キレート剤として先ずs-thalassemia患者での試験データに基づき2005.11に迅速承認されたが、FDAのBlood Products 諮問委は2005.9.29審議ではsickle cell disease, myelodysplastic syndromes, or other hemotrophic disordersに対する追加試験データを要求していた。※Brief Information
※【審議結果】
Exjade (Deferasirox)
  2006.03.13 Lilly Gemzar For Advanced Ovarian Cancer; Preclinical Requirements And Phase I Trial Design Issues 
※Gemzarは乳癌・非小肺癌・膵臓癌に既適応を認可されているが、今回進行性膀胱癌の追加適応を申請。※Brief Information
※【審議結果】11-2、保留1で否決。
Gemzar(gemcitabine)
  2005.11.08 Oncologic Drugs Accelerated Approval Phase IV Commitments 
※※Brief Information
※【審議結果】
 
  2005.10.20 Off-Patent Oncology Drugs Needing Pediatric Studies; Postmarketing Studies for Oncologic Drug Indications 
※※Brief Information
※【審議結果】
 
1228 2005.09.14 Celgene Revlimid For Myelodysplastic Syndromes; GSK Arranon For T-cell Lymphoblastic Leukemia, Lymphoma 
【Arranon[GSK]】※本剤はT細胞急性リンパ芽球性白血病およびT細胞リンパ芽球性リンパ腫の適応承認を求めていた。※Brief Information※【審議結果】成人の臨床benefitは全員一致、小児の臨床benefitは11-1で勧告。 骨髄芽球数5%以内と末梢血球数の完全回復という完全寛解[CR]の定義に照らして、CRは小児13%、成人18%だった。 効果についてのデータが最小限であるため、GSKは6年間のP3確認試験を実施し640例を収集、Event-free survival を主要エンドポイントとする。
【Revlimid[Celgene]】※骨髄異形成症候群(myelodysplastic syndrome;MDS)の適応をPhase IIデータに基づき申請。 ※Brief Information
※【審議結果】諮問委はrisk/benefit分析について10-5だったが効果について疑義なしとの意見。しかしCelgene社のsingle-arm試験が「推奨用量に根拠がなく、安全性プロファイルの記述不十分」ということに、13-2。 患者の80%がneutropenia and thrombocytopeniaの毒性のため用量減少している。
Revlimid[Celgene]
Arranon[GSK]
  2005.09.13 Abbott Xinlay For Prostate Cancer; Genentech/OSI Tarceva Pancreatic Cancer sNDA 
※※Brief Information
※【審議結果】
Xinlay[Abbott]
Tarceva[Genentech/OSI]
  2005.05.05 J&J Zarnestra For Acute Myeloid Leukemia
※J&JはP2データに基づき急性骨髄性白血病[AML]の適応での優先審査を求めた。※Brief Information
※【審議結果】7-4で否決。P3結果を見てからとする。
Zarnestra (tipifarnib)
  2005.03.04 AstraZeneca Iressa Confirmatory Trial; Novartis Zometa & Aredia Osteonecrosis Safety Issues
【Iressa】※イレッサは進行性あるいは転移性非小細胞肺癌に対してプラチナ・docetaxel 両剤失敗例の場合の適応を、2003.5にFDA承認されたわけだが、平均10.6%のobjective tumor response rateで迅速承認を受けたものなので、生存率などのOutcomeデータの追加が要請されていたもの。 AstraZeneca社は昨2004.12、肺癌1,692例での生存率評価試験の予備報告で、イレッサがプラセボより明白に生存率が勝るという実証に失敗。 イレッサ5.6カ月、プラセボ5.1カ月。※Brief Information
【ZometaとAredia】※ノバルティス社は同社ビスホスホネート製剤Zometa (zoledronic acid)とAredia(pamidronate)が顎の骨壊死(osteonecrosis)リスクを持つとのドクターレターを2004.9月17,000人以上の癌専門医、泌尿器科医、血液専門医、口腔外科医に送付。 これに関連して、審議した。 FDAにはbisphosphonatesによる顎の骨壊死(osteonecrosis)症例が134件(2001-2004.5)報告されている。※Brief Information
※【審議結果〜Iressa】今回の投票はイレッサのデータについて患者と医療関係者に対する広報が十分に実施されたかという1点のみ。これは十分との評価だった。 販売の継続に関しては審議されなかったが、委員数名は、代替え薬がないとの理由から、存続を求めた。
※【審議結果〜bisphosphonates】ドクターレターは歯科医にも配布すべきという結論。
Iressa(gefinitib)
Zometa (zoledronic acid)
Aredia(pamidronate)
  2005.03.03 Advanced Magnetics Combidex For Lymph Node Imaging; Prostate Cancer Clinical Endpoints※「前立腺癌のリンパ節転移の検出」の適応での新薬承認審議
※Brief Information
※【審議結果】15-4で否決。 Combidexを用いたMRI造影は20%の判定エラー率であり、生検の代替えとはならない。 効果データ不足。
Combidex (ferumoxtran-10)
  2004.12.02 Berlex Bonefos For Breast Cancer Bone Metastases[乳ガン骨転移]
※NDA (21-776)2004.9.9申請(filing)、User fee申請はMarch 9, 2005見込み。 本剤はAnthra Pharmaceuticalsが数年前に「骨転移」で申請したもので、Berlex社(独Schering AGの子会社)はFDA-NDA承認後の販売権取得オプション契約を締結している。 しかしながら前回の諮問委(Dec. 4, 2001予定)は、FDAの追加データ要求に対してAnthra社が回答するためのデータ収集に時間を必要としていたため延期されたままの状態。 ちなみにBenefosは米国外では1985年から販売されている。
Bonefos
(clodronate)
  2004.12.01 Ilex Clolar For Refractory Leukemia; Inex/Enzon Marqibo For Aggressive Non-Hodgkin's Lymphoma
※Marqibo(Inex/Enzon)2種以上の多剤併用療法失敗例に対する非ホジキン性リンパ腫のmonotherapyの適応で申請。 Inexは2004.3.12にrolling NDA申請(2005.1.15日付けUser Fee)。申請はPIVOTAL (sPhingosomal Vincristine for the Treatment of Aggressive Lymphoma) P2/3 studyに基づき、25%の反応があり、progressionへの平均期間は3カ月。
※Clolar[Ilex]は難治性白血病の適応申請。
Marqibo(旧名Onco TCS)(liposomal vincristine)[Inex/Enzon]
Clolar
(clofarabine)
1180 2004.07.27 Lilly Alimta For Non-Small Cell Lung Cancer
※抗葉酸剤。 非小細胞肺癌のsecond-line治療への適応追加。本剤は2004.2.4に中皮腫(malignant pleural mesothelioma)の適応で認可されている。2004-Q1売上は mil., including mil. in initial stocking.
※[審議結果]13-0で承認勧告。 docetaxel (Aventis' Taxotere)と比較され、効果について疑義があったものの、低毒性プロフィルが評価された。
Alimta
(pemetrexed)
  2004.05.04 1)Amgen Aranesp(darbepoetin alfa)/Ortho Procrit(epoetin alfa) Safety Issues; 2)Colorectal Cancer Endpoint Workshop
※epoetin alfa&darbepoetin alfa 両剤は共にAmgen社開発で、癌化学療法による貧血を適応とする。 Amgen社及びOrtho親会社J&JはAranesp (darbepoetin alfa)およびJ&Jの米国外epoetin alfa製剤Eprexの赤血球無形成症例[pure red cell aplasia=PRCA]を報告。 Procritは、epoetin alfaの米国商品名で、製造Amgen,販売Ortho。 このPRCA症例の発生で、J&Jは2002年にEprexの欧州添付文書を変更、現在皮下注のかわりに静注を推奨。PRCAが皮下注で大半が発生するため。 またOrtho Biotech社はProcritの週1回投与の追加申請をFDAに提出済み。
今回の審議は、第一にこれらEPO系製剤が癌を増殖させているのではないか?との疑い、第二にEPO製剤が血栓リスクを惹起させるという副作用があり、これらを含めてEPOの安全性を再審議しようとするもので、2つの欧州実施の大規模臨床試験結果を踏まえて審議。詳細は→※Brief Information
※同日にNeorecormon (Epoetin Beta), Hoffman-La Roche, Ltd の安全性も審議される。ロシュ社は後に開催予定のEPO安全性問題に関するFDA諮問委に備えてthe continuous erythropoeisis receptor activator (CERA) R-744 と名付けたプログラムを実施予定。
※[審議結果]Amgen社はAranespについて現在乳癌、頭頚部癌、リンパ腫、小細胞肺癌の5種の効果についての臨床試験を実施中で、そのエンドポイントはrelapse-free survival(RFS) and regional control(無再発生存期間と原発巣制御)。 J&J社はProcritとEprexの効果について転移性乳癌の臨床試験を実施予定だがエンドポイントをprogression-free survival(PFS:無増悪生存期間)とする。 諮問委委員側は、これら臨床試験について"progression-free survival"を"primary endopoint"とすることに賛成。 委員の強調点としては、「臨床試験はまた、Overall survival[OS:生存期間]に対する効果を示すべき」とした。
Aranesp (darbepoetin alfa)
Procrit(epoetin alfa)
  2004.05.03 Aventis/Genta Genasense For Malignant Melanoma; Allos Efaproxiral Radiation Sensitizer For Brain Metastases
※Genasenseは2003夏にthe rolling NDAを開始、2003.12.8申請した。 適応症は進行性メラノーマ患者で化学療法剤(dacarbazine)との併用。
※Allos Therapeutics社の放射線増感剤RSR13=Excelar (efaproxiral)は乳癌に伴う脳転移(brain metastases)を適応とする。脳への放射線療法の補助剤としてrolling NDAを開始、12.4 臨床効果と安全性試験を終了したもの。
※Brief Information
※[審議結果]転移性メラノーマに対してGenasense (oblimersen) plus dacarbazineの方がDTIC単独よりも有効とする委員が11:5。 しかしGenta社のpivotal trialがprogression-free survival(PFS:無増悪生存期間)に関して"本当の効果"があると結論できない。とする委員が12:5。
※[審議結果]efaproxiralの乳癌患者へのP3研究は、放射線増感剤としての効果を実証するものではないとの否定的意見が大半(16:1)を占め否認された。 しかしAllos社は乳癌の脳転移に関するENRICH trialを2月に開始している。
Genasense (oblimersen sodium)
RSR13 (efaproxiral)
  2004.03.17 Pediatric Cancer Trial Safety Monitoring, Use Of Nonclinical Data
※2003.2の原稿ガイダンス"Nonclinical Safety Evaluation of Pediatric Drug Products," では、FDAは小児における年齢相関毒性を予測するために幼令動物の使用を要求した
 
  2003.12.16 Non-Small Cell Lung Cancer Trial Endpoints
これはFDA/ASCO(米臨床腫瘍学会)合同Workshop(2003.4.15)の結果に基づき提出すると、FDAが言明していた今秋のODAC[Oncologic Drug Advisory Committee]への白書について、臨床試験デザインとエンドポイントを審議するもの。問題を起こしたIressa[AstraZeneca]を含む最近の数種のNSCLC剤のレビューも行われている。※FDA Project on Cancer Drug Approval Endpointsに詳細資料
 
  2003.11.12 Colorectal Cancer Endpoints Public Workshop
※FDA Project on Cancer Drug Approval Endpoints
-FDA PUBLIC WORKSHOP ON CLINICAL TRIAL ENDPOINTS IN COLORECTAL CANCER
※従来FDAの制癌剤の承認基準は「延命率」をベースとしてきた。 しかし現在その基準の妥当性の見直しを行っており、今回は大腸癌について
 
  2003.10.9 Pediatric Studies For Off-Patent Oncology Drugs
※追加情報が必要かどうか? NIHはFDA,USPの協力のもと、the Best Pharmaceuticals for Children Act of 2002に従って特許切れ医薬品で小児用追加試験を必要とするもののリストを作成している。
 
  2003.7.15 Pediatric Oncologic Drug Multi-National Trials; Pharmacogenetic Testing For TPMT Deficiency  
  2003.03.04 Oncologic Drug Pediatric Labeling
※焦点はFDA’s role in prioritizing therapies for pediatric development and expanded access programs for children
 
  2003.03.12 Oncologic Accelerated Approval Phase IV Commitments - Day 1 (Doxil, Ontak, Ethyol)
※Doxil (liposomal doxorubicin) [J&J/Alza]の2つの適応:エイズ患者のカポジ肉腫と再発性転移性卵巣癌[refractory metastatic ovarian cancer]のPhase4
※Ontak (denileukin diftitox) [Ligand]の再発性皮膚T細胞リンパ腫[recurrent cutaneous T-cell lymphoma]治療
※Ethyol (amifostine)[MedImmune]の進行性非小細胞肺癌に対するシスプラチン併用療法時腎毒性軽減
 
  2003.03.13 Oncologic Accelerated Approval Phase IV Commitments - Day 2 (Mylotarg, DepoCyt, Celebrex, Temodal)
※Wyeth's Mylotarg (gemtuzumab)はCD33陽性急性骨髄性白血病P4
※Skye Pharma's DepoCyt (cytarabine)はリンパ腫様髄膜炎の髄腔内注射(for intrathecal treatment of lymphomatous meningitis)
※Pfizer/Pharmacia's Celebrex (celecoxib)は線腫様の大腸直腸ポリープ縮小
※Schering-Plough's Temodal (temozolomide) は再発性未分化〔神経膠〕星状細胞腫P4
 
1168 2002.12.17 GlaxoSmithKline/Corixa Bexxar Review
※Brief Information
【審議結果】※Corixa社Release- 非ホジキン性リンパ腫tositumomab - 10-3でクリア
Bexxar(tositumomab)
0977 2002.12.18 AstraZeneca Casodex For Non-Metastatic Prostate Cancer (ビカルタミド)
  2002.10.17 Pediatric Oncology Trial Timing  
1138 2002.09.24 AstraZeneca Iressa Review
※Brief Information
Iressa(gefinitib)
  2002.02.27 Corixa Melacine Phase III Trial Design
※Corixa社Release- メラノーマ・ワクチン
 
  2002.01.31 Novartis Zometa For Bone Metastases In Cancer (zaledronic acid)
  2001.12.6 Pharmacia Camptosar Postmarketing Safety Issues; Guilford Gliadel  
  2001.12.5 Genentech Herceptin Use With PathVysion Test; Development of Immun  
  2001.11.28 Pediatric Oncology Study Design Discussion  
1144 2001.09.11 Idec Zevalin For Non-Hodgkin's Lymphoma
※Brief Information
Zevalin(ibritumomab tiuxetan)
  2001.09.10 Matrix IntraDose For Head and Neck Cancer
※Matrix Gets a Painful Lesson From the FDA[2001.9.7]
頭頸部腫瘍DDS
  2001.06.28 Pediatric Indications For CNS Solid Tumor Drugs  
  2001.06.7 Oncologic Drug Compassionate Use  
  2001.04.24 Pediatric Indications for Leukemia/Lymphoma Drugs  
1307 2000.12.14 Ilex/Millennium Campath Committee Review
※リンパ性白血病
※資料Briefing Information | スライド | 議事要旨Minutes | 【審議結果】
(Alemtuzumab)
製品サイトwww.campath.com
  2000.12.13 Maxim Maxamine Committee Review
※黒色腫治療薬:関連記事
※資料Briefing Information | スライド | 議事要旨Minutes | 【審議結果】
 
1024 2000.12.13 Novartis Femara Committee Review
※資料Briefing Information | スライド | 議事要旨Minutes | 【審議結果】
(letrozole)乳癌
  2000.09.12 Pediatric Oncologic Drug Development For Limited Patient Populati  
1083 2000.03.17 Wyeth-Ayerst Mylotarg For Relapsed Myeloid Leukemia
※Brief Information|Transcript-1|Transcript-2|Slides
(Gemtuzumab Ozogamicin)
骨髄性白血病
FDA承認=19-May-2000
1148 2000.03.16 Sanofi Eloxatin For First-line Treatment Of Colorectal Cancer※Briefing Information:Oxaliplatin (Oxaliplatin)
FDA承認09-Aug-02
0992 2000.03.16 Pharmacia Camptosar For First-line Metastatic Colorectal Cancer (irinotecan) 
  2000.02.10 Oncologic Drugs Quality of Life Subcommittee Meeting  
ML 開催日 議題 備考
     
1507 2016.04.25 (NDA) 206488, eteplirsen injection for intravenous infusion, sponsored by Sarepta Therapeutics, Inc., for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping. 
※資料※Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript【審議結果】[eteplirsenが臨床ベネフィットを示すに程度にdystrophin産生を引きおこすことを示したか?]Y=5,N=8,保留=0 [十分な客観的かつ偏見なく主観的な意思決定が患者、介護者、および/または医療従事者によって6分間歩行試験(vs. 患者もはや歩くことはできなかった)を実施する決定があったが、試験201/202の患者と外部対照群との間に有効な比較を可能にしたか?]Y=5,N=7,保留=1 [North Star Ambulatory AssessmentはStudy 201/202の発見の説得力に影響力を示したか?]強化=2,弱化=5,無効=6 [他の物理的テスト(立ち上がり時間、10メートル走行)はStudy 201/202の発見の説得力に影響力を示したか?]強化=1,弱化=2,無効=10 [歴史的に統制された単一の研究(研究201/202)の臨床結果は、エテプリルセンがDMDの治療のために有効である実質的な証拠(すなわち、有効性を実証する独立した知見を伴う十分かつ十分に管理された研究からの証拠または非常に説得力のある適切で十分に管理された単一の研究からの証拠)を示したか?]Y=3,N=7,保留=3
eteplirsen
  2015.11.24 (NDA) 206031, drisapersen solution for injection, sponsored by BioMarin Pharmaceutical Inc., for the treatment of patients with Duchenne muscular dystrophy with mutations in the dystrophin gene that are amenable to treatment with exon 51 skipping as determined by genetic testing. 
※資料※Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript【審議結果】[Study 1はQ1(有効性の強化)に説得力を強化したか?]強化=1,弱化=9,無効=7 [Study 2はQ2(有効性の強化)に説得力を強化したか?]強化=0,弱化=5,無効=12 [Study 3はStudy 1&2の発見の説得力に影響力を示したか?]強化=0,弱化=15,無効=2 [ジストロフィン産生の結果が臨床結果の解釈に及ぼす影響?]強化=0,弱化=6,無効=10,保留=1
drisapersen
1441 2013.11.14 (NDA) 205677, tasimelteon capsules, proposed trade name HETLIOZ, submitted by Vanda Pharmaceuticals, Inc. The proposed indication is for the treatment of Non-24 hour sleep-wake disorder in blind individuals without light perception. 
※資料※Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript【審議結果】[有効性〜非24時間睡眠覚醒症候群がFDA承認医薬品の適応症として適切か?]Y=10,N=1,保留=0 [有効性〜tasimelteonの臨床試験エンドポイントが非24時間睡眠覚醒症候群の適応症を支持するに適当か?]Y=10,N=1,保留=0 [有効性〜tasimelteonの非24時間睡眠覚醒症候群の有効性のエビデンスがあるか?]Y=10,N=0,保留=1 [安全性〜tasimelteonの非24時間睡眠覚醒症候群の安全性は十分か?]Y=11,N=0,保留=0
tasimelteon
  2013.11.13 (sBLA) 103948-5139, alemtuzumab injection, proposed trade name LEMTRADA, submitted by Genzyme Corporation, a Sanofi Company. The proposed indication is for the treatment of patients with relapsing forms of multiple sclerosis to slow or reverse the accumulation of physical disability and reduce the frequency of clinical exacerbations. 
※資料※Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript【審議結果】Y=,N=,保留=
alemtuzuma
  2013.05.22 (NDA) 204569, for suvorexant tablets, submitted by Merck Sharp and Dohme Corp., Worldwide Regulatory Group. The proposed indication is for insomnia characterized by difficulties with sleep onset and/or maintenance. 
※資料※Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript【審議結果】Y=,N=,保留=
suvorexant
  2012.05.24 (NDA) 202737 for tafamidis meglumine capsules, proposed trade name VYNDAQEL, submitted by FoldRx Pharmaceuticals, Inc. a subsidiary of Pfizer, Inc. The proposed indication is for the treatment of transthyretin (TTR) familial amyloid polyneuropathy 
※資料※Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript【審議結果】[study 005は有効性を実証したか?]Y=4,N=13,保留=0 [study 005は臨床的ベネフィットを予測するバイオマーカーエンドポイントとする二つの支持研究と同様の有効性エビデンスを備えるか?]Y=13,N=4,保留=0
tafamidis
  2011.10.17 supplemental new drug application (sNDA) 21641 (013) for AZILECT (rasagiline mesylate) Tablets, manufactured by Teva Neuroscience, Inc., for the following proposed indication: Treatment of patients with idiopathic (of unknown cause) Parkinson's disease to slow clinical progression and treat the signs and symptoms of Parkinson's disease as initial monotherapy (the single drug used to treat) and as adjunct (additional) therapy to levodopa 
※資料※Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript【審議結果】[ADAGIOはプロトコールとして適切か?]Y=0,N=17,保留=0 [2mg群はプロトコールで失敗したか?]Y=17,N=0,保留=0 [rasagilineのパーキンソン病の有効性に関して、臨床的進展遅延に成功したか?]Y=0,N=17,保留=0
AZILECT (rasagiline mesylate)
  2011.03.10 the supplemental new drug application 022115/S-011, LAMICTAL XR (lamotrigine extended-release tablets), sponsored by SmithKline Beecham Corp. d/b/a GlaxoSmithKline, for monotherapy in patients 13 years of age and older with partial seizures who are receiving therapy with a single antiepileptic drug.
※資料※Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript【審議結果】[併用療法としての有効性]Y=14,N=0,保留=0 [部分てんかんの単独療法での有効性のエビデンス]Y=10,N=2,保留=1 
lamotrigine
  2011.01.21 NDA 201-277, gadobutrol injection, sponsored by Bayer HealthCare Pharmaceuticals, proposed for use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity (abnormal blood supply and circulation) of the central nervous system. The BBB is an area consisting of specialized cells that restrict passage of certain molecules from the bloodstream into the brain.
※資料※Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript【審議結果】[gadobutrolの臨床試験データは承認に十分?]Y=16,N=0,保留=0 [gadobutrolの添付文書でNSF(腎性全身性線維症)の禁忌は省いて良いか?]Y=15,N=1,保留=0 
gadobutrol
1394 2011.01.20 (NDA) 202-008, florbetapir F 18 injection, sponsored by Avid Radiopharmaceuticals, Inc., proposed for use in positron emission tomography (PET) imaging of β-amyloid (beta-amyloid) aggregates in the brain to help rule out Alzheimer's disease.
※資料※Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript【審議結果】[提出データでAmyvid™の承認に十分?]Y=3,N=13,保留=0 [訓練プログラム等により迅速診断を示すとしたら、提出データでAmyvidを承認?]Y=16,N=0,保留=0 
florbetapir F 18
  2010.11.03 a number of safety concerns with intravenous administration of the anti-seizure drugs phenytoin and fosphenytoin, including the condition known as Purple Glove Syndrome (PGS), and recommend what regulatory actions, if any, are necessary to diminish the risks.
※資料※Briefing Information | Slides | 議事要旨Minutes【審議結果】[静注フェニトインはPurple Glove Sundrome(PGS)を引き起こすか?]Y=26,N=2,保留=1 [FosphenytoinはPurple Glove Sundrome(PGS)を引き起こすか?]Y=11,N=18,保留=0 [重篤なPGSの発生頻度の十分な情報はあるか:フェニトイン]Y=9,N=18,保留=1 [重篤なPGSの発生頻度の十分な情報はあるか:Fosphenytoin]評決せず [諮問委はフェニトインの販売中止を求めるべきか?]Y=0,N=29,保留=0 [フェニトインの配合禁忌や用法について添付文書の改訂すべきか?]Y=29,N=0,保留=0 [FosphenytoinにPGS等リスクに関して法規制を要求すべきか?]Y=29,N=0,保留=0 
fosphenytoin
1397 2010.08.11 (NDA) 22-345, with the proposed trade name POTIGA (ezogabine) Tablets, by Valeant Pharmaceuticals North America. The proposed indication for this new drug product is adjunctive therapy in patients with partial-onset seizures
※資料※Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript【審議結果】[有効性]Y=13,N=0,保留=0 [尿貯留リスクが安全性の課題か?]Y=11,N=0,保留=2 [感染と尿路結石症をモニタリングすべきか?]Y=0,N=13,保留=0 
ezogabine
1353-4 2010.06.10 (NDA) 22-527, with the proposed trade name GILENIA (fingolimod hydrochloride) 0.5 milligram (mg) capsules, by Novartis Pharmaceuticals Corporation. The proposed indication for this new drug product is treatment of relapsing forms of multiple sclerosis. 
※資料※Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript【審議結果】[再発寛解型多発性硬化症の治療上で臨床的悪化を低減する効果のエビデンスを提示したか?]Y=25,N=0,保留=0 [身体機能障害の遅延効果は?]Y=24,N=1,保留=0 [1日1回0.5mg未満での効果のデータを要求すべきか?]Y=20,N=5,保留=0 [それは承認前に?]Y=0,N=24,保留=0 [0.5mgでの安全性データで承認するか?]Y=25,N=0,保留=0 [初期投与で徐脈や心臓伝導異常を生ずることがある。 初期投与のモニタリングを要求すべきか?]Y=25,N=0,保留=0 [本剤は黄斑浮腫を生ずることがある。 ルーチンの眼科検査で十分か?]Y=4,N=20,保留=1 [肺機能の低下を生ずることがある。 ルーチンの医薬品安全性監視(pharmacovigilance)で十分か?]Y=7,N=17,保留=1 [リスク/ベネフィットを考慮してfingolimodの効果のない患者に別の治療法を推奨すべきか?]Y=3,N=21,保留=1 
fingolimod
  2010.05.06 (sNDA) 22-432, H.P. ACTHAR Gel (repository corticotropin injection), 80 USP units per milliliter, Questcor Pharmaceuticals, proposed for the treatment of infantile spasms. 
※資料※Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript【審議結果】[有効性]Y=22,N=1,保留=0 [2週コース]Y=16,N=7,保留=0 [副作用]Y=10,N=12,保留=1 [有効用量での安全性]Y=20,N=1,保留=2 
corticotropin
1347 2009.10.14 (NDA) 22-250, with the proposed trade name AMAYA (fampridine) 10 milligram (mg) tablets, manufactured by Acorda Therapeutics, Inc. The proposed indication for this new drug product is to improve walking ability in individuals with multiple sclerosis (MS). MS is a neurological disease that may cause a wide variety of possible symptoms, including in some patients difficulty in walking. 
※資料※Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript【審議結果】[効果]Y=12,N=1,保留=0 [10mg以下1日2回の効果]Y=12,N=1,保留=0 [承認前の追加データ要求]Y=2,N=11,保留=0 [安全性]Y=10,N=2,保留=1
fampridine
  2009.08.11 NDA 22-454, Ioflupane I 123 Injection (proposed trade name DaTSCAN), GE HealthCare, is proposed for detecting loss of functional nigrostriatal dopaminergic neurons by single photon emission computed tomography (SPECT) imaging in patients presenting with symptoms or signs of dopaminergic neurodegeneration. 
※資料※Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript【審議結果】Y=11,N=2,保留=1
Ioflupane I 123
1332 2009.1.7 (NDA) 20-427, vigabatrin, Ovation Pharmaceuticals, Inc., for the proposed indication of adjunctive therapy for the treatment of refractory complex partial seizures in adults.
※資料Briefing Information[FDA563p+メーカー197p] |スライド(1)[118p+]| 議事要旨Final Minutes 2009.1.7[7p] | 議事録Transcript(未) 【審議結果】 [2009.1.7] 1.Vigabatrinは不可逆性の視力低下を引き起こすが  a)ある患者にとってvigabatrinの連続使用は有意な視力低下をもたらす信ずるか? (Does the committee believe that continued treatment results in a clinically meaningful loss of vision in some patients?〜訳は正しいか?)  〜公式の賛否を採決していないが大半の意見はYes。 Transcript(議事録)を参照のこと。  b)メーカー側は視力低下の検出可能性を示したか?  〜賛成14 反対7 保留3  c)メーカー側は投薬中止による視力低下進行停止を実証したか?  〜公式の賛否を採決していないが委員会の合意ではNo(不十分)。 Transcript(議事録)を参照のこと。  d)メーカー側はvigabatrinは中枢性視力低下を起こさないと主張するが、実証したか?  〜公式の賛否を採決していないが委員会の合意ではNo(不十分)。 Transcript(議事録)を参照のこと。 2.委員会は患者と使用条件の組み合わせで承認を支持する条件を思い描くことができるか?  〜賛成24 反対0 保留0 3.質問2に関連して  a)該当する患者人口がどのくらいであるか、(例えば、てんかんを伴う患者とか、外科患者や内科系難治性患者の一部とか)  b)Sabrilを再発性患者に承認する場合、特にこの患者層での有効性(比較)データを追加するべきか?  〜公式の賛否を採決していないが委員会の合意ではNo(不要)。 Transcript(議事録)を参照のこと。 4.質問2にYesの場合、Sabrilの承認条件は何か? 例えばRisk Evaluations and Mitigation Strategy (REMS)  〜公式の賛否を採決していないが委員会の合意では、Sabrilは限定条件下でのみ使用すべきこと、 また眼科医のモニタリングを義務づけるべきこと。 Transcript(議事録)を参照のこと。 5.眼科モニター計画を推奨するような何かエビデンスがあるか?  a)一定期間の眼科モニターを要求すべきか?  〜公式の賛否を採決していないが委員会の合意ではYes。  b)もしそうなら、メーカー側のモニター計画は十分か?  〜公式の賛否を採決していないが委員会の合意ではNo(不十分)。 Transcript(議事録)を参照のこと。  c)メーカー側のモニター計画が不十分としたら、どんな提案をするか?  〜委員会の推奨する眼科モニタリングは、視野測定を3ヵ月目、次回以降4-6ヵ月毎に実施。 Sabril (vigabatrin)投薬中止時は一定期間実施。 Transcript(議事録)を参照のこと。 6.Sabrilの承認前に得るべき視力低下関連の追加データはあるか? もしYesなら、それは何か?  〜公式の賛否を採決していないが委員会の合意ではNo(不要)。 Transcript(議事録)を参照のこと。 7.動物で観察されたミエリン内の浮腫が、成人人体の臨床上問題となるか?  〜公式の賛否を採決していないが委員会の合意ではNo(不要)。 Transcript(議事録)を参照のこと。 8.質問7にYesの場合、臨床的に追加要求すべきか?(例えば追加モニター、追加分析、追加データ)  〜公式の賛否を採決していないが委員会の合意ではNo(不要)。 Transcript(議事録)を参照のこと。 9.現在のデータで、Sabrilを「成人の再発性の複雑部分発作の治療」で承認すべきか?  〜賛成24 反対0 保留0 [Lunbeck]Ovation社プレスリリース[2009.1.7]
vigabatrin
1332 2009.1.8 NDA 22-006, vigabatrin, Ovation Pharmaceuticals, Inc., for the proposed indication of treatment of infantile spasms
※資料Briefing Information[FDA563p+メーカー197p]|スライド(2)[114p+]| 議事要旨Final Minutes 2009.1.8[8p] 【審議結果】 [2009.1.8] 1.メーカー側はvigabatrinの点頭てんかんの治療薬としてエビデンスを示したか?  〜賛成25 反対0 保留0 2.臨床試験は次の点の有効性を示したか?  a)痙攣の停止  〜公式の賛否を採決していないが委員会の合意ではYes。 Transcript(議事録)を参照のこと。  b)EEGの改善  〜公式の賛否を採決していないが委員会の合意ではYes。 Transcript(議事録)を参照のこと。  c)他のタイプのてんかん予防  〜公式の賛否を採決していないが委員会の合意ではNo。 Transcript(議事録)を参照のこと。  d)長期の発達障害の改善  〜公式の賛否を採決していないが委員会の合意ではNo。 Transcript(議事録)を参照のこと。 3.現行の未承認の治療法(ACTHやステロイド)が短期療法(約2週間)により点頭てんかんから長期的に 防護する、という意見がある。 メーカー側によると、VIGABATRINのRCTでの長期投与で、短期療法を上回るBenefitは認めなかった。 メーカー側にこの点に関する十分な試験を要求すべきか?  〜公式の賛否を採決していないが委員会の合意ではYes(但し市販後)。 Transcript(議事録)を参照のこと。 4.vigabatrinは不可逆性の視力障害を引き起こすが、メーカー側はERG(網膜電図/Electroretinogram) モニタリングで早期発見可能としている。  a)ERGの信頼性をメーカー側は立証したか?  〜公式の賛否を採決していないが委員会の合意ではNo。 Transcript(議事録)を参照のこと。  b)視力障害の早期発見の他の方法をメーカー側は提示したか?  〜公式の賛否を採決していないが委員会の合意ではNo。 Transcript(議事録)を参照のこと。  c)もし委員会がメーカー側の検出方法が十分と判断した場合、モニタリングRegimenについてのエビデンス があるのか?  〜公式の賛否を採決していないが委員会の合意ではNo。現在視力障害の検出および予測の信頼性ある実際的な手段 は存在しない。 小児神経科専門医以上の手段はないことに合意。 従って、視力障害の発生時、重篤かつ不可逆である可能性が高いことを家族に説明する。 Transcript(議事録)を参照のこと。  d)もしモニタリングRegimenについてのエビデンスが不十分な場合、メーカー側に開発を要求するか?  e)もし委員会がメーカー側の検出方法が不十分と判断した場合、メーカー側に開発を要求するか?  f)視力障害が発見されvigabatrin投薬か中止された場合、視力低下が進行しないことを、メーカー側は十分に示したか?  〜公式の賛否を採決していないが委員会の合意ではNo。 Transcript(議事録)を参照のこと。  g)vigabatrin治療の視力システムの進展および機能全般(特に先在する神経異常に対して)に及ぼす機能的結果 について、メーカー側は十分エビデンスを示したか?  〜公式の賛否を採決していないが委員会の合意ではNo。 Transcript(議事録)を参照のこと。 5.中枢性視力障害が小児患者に発生しないという十分なエビデンスを、メーカー側は提示したか?  〜公式の賛否を採決していないが委員会の合意ではNo。 Transcript(議事録)を参照のこと。 6.承認を前提とした、患者層および使用条件の組み合わせに関して、委員会の方策は?  〜委員会は、この質問がこの一日の論点であると感じた。 Transcript(議事録)を参照のこと。 7.質問6に関してYesの場合、  a)何が適切な対象患者層であるのか? (点頭てんかん患者全部、特定の年齢層、結節性硬化症等の病因サブセット 、他の治療法の失敗例)  〜公式の賛否を採決していないが委員会の合意では、特定の患者層に使用制限するのではなくて 、点頭てんかん患者全部で承認すべき。 Transcript(議事録)を参照のこと。  b)Sabril (vigabatrin)が特定のサブセットの患者層での使用に限定して承認する場合、この患者層についての 有効性試験を追加要求すべきか?  〜公式の賛否を採決していないが委員会の合意ではNo。 Transcript(議事録)を参照のこと。 8.質問6に関してYesの場合、Sabril (vigabatrin)を特定環境下で承認すべきか? 例えば、Risk Evaluations and Mitigation Strategy (REMS)管理下で? 以下はREMPの主要部分  a)限定条件下、例えば特定臨床医に限定、流通上の制限、医師向け研修や訓練プログラム 、登録管理(患者、医師等)、などでの使用制限すべきか?  〜公式の賛否を採決していないが委員会の合意ではREMS管理下に使用制限すべき。 なお、複雑再発性部分発作と点頭てんかんでは、REMSの内容を変えるべき。 Transcript(議事録)を参照のこと。  b)当該薬剤の継続アクセスを眼科モニタリング結果にリンクすべきか?  c)他に何か? 9.代替のオフラベル療法(ACTH,バルプロ酸など)があることを考慮して、本剤の安全性に対する懸念は、 効力が示されたとしても市販を排除する程ですか?  〜公式の賛否を採決していないが、臨床上MRI所見で相関関係を認めなかったとの意見あり。 委員会はこの質問に対するデータを持っていない。 Transcript(議事録)を参照のこと。 10.動物で観察されたミエリン内浮腫が、小児患者に何か臨床的問題を生じさせると委員会は信じますか?  〜公式の賛否を採決していないが委員会の合意ではNo。 Transcript(議事録)を参照のこと。 11.若年動物に神経細胞空胞変性が観察された場合の臨床的所見は何かありますか?  a)小児のMRI所見が灰白質損傷に関連ありとするか?  b)小児のMRI観察が動物の神経細胞空胞変性と関連あると、委員会が信じない場合、 それでも臨床上の懸念ありますか?  〜公式の賛否を採決していないが、委員会はこの質問に対するデータを持っていない。  Transcript(議事録)を参照のこと。 12.Sabrilの点頭てんかんに対する承認の前に、追加する安全性データはありますか?  もしYesなら、それは何か?  〜公式の賛否を採決していないが委員会の合意ではNo。 Transcript(議事録)を参照のこと。 13.現在のデータで、Sabrilを「点頭てんかん の治療」で承認すべきか?  〜賛成23 反対0 保留0 [Lunbeck]Ovation社プレスリリース[2009.1.8]
vigabatrin
  2008.10.23 the clinical development of radionuclide imaging products for the detection of amyloid to assist in the diagnosis of Alzheimer's Disease〜“for PET imaging of amyloid plaque pathology in the brain to aid in the evaluation of patients with signs or symptoms of cognitive impairment.”(Avid Radiopharmaceuticals)〜“the PET tracer can detect amyloid beta plaque in the brain. In the absence of tracer uptake (and thus amyloid s plaque deposition) Alzheimer's disease can be excluded.”(Bayer HealthCare)〜“PET imaging of brain beta amyloid deposition.”(GE Healthcare)
※資料Briefing Information | 議事要旨Final Minutes
 
1332 2008.08.06-07 延期(利害関係者を除く委員の定数不足)★NDA20-427, vigabatrin, Ovation Pharmaceuticals, Inc., (2008.8.6) for the proposed indication of adjunctive therapy for the treatment of refractory complex partial seizures in adults. (2008.8.7)NDA 22-006, vigabatrin, Ovation Pharmaceuticals, Inc., for the proposed indication of treatment of infantile spasms vigabatrin
  2008.07.10 抗てんかん薬の自殺等のリスク(精神薬理諮問委合同) 
※資料Briefing Information | 議事録Transcript | 審議結果Minutes
 
  2007.12.06 tetrabenazine[Prestwick Pharmaceuticals Inc] NDA 21-894 - indication to treat chorea associated with Huntington's disease
※資料Briefing Information - ※slide | 議事録Minutes
 
  2006.09.06-07 Dental Amalgam Devices
※Brief Information
※【審議結果Minutes】2)FDA draft White Paperがdental amalgamの健康被害評価に十分か?は7:13否決。 3)FDA draft White Paperの結論に賛成か?は7:13否決。
 
  2006.05.17 Novartis' Exelon For Dementia Associated With Parkinson's Disease※Brief Information Exelon
  2006.03.08 Biogen Idec/Elan Tysabri Safety, Potential Market Re-Entry
※Tysabriは2004.11にFDA承認を受けた後、臨床治験患者にPML(progressive multifocal leukoencephalopathy:進行性多巣性白質脳症)が3例発症したたため2005.2に製品回収していた。The sBLA は2005.9に申請されたものでBiogen Idec/Elan社発表では3,000症例でPML発症はゼロ件。
※会議記録 | 資料Brief Information
※【審議結果Minutes】全員一致で承認勧告。 しかし既存のfirst-line therapies (beta interferon (Biogen Idec's Avonex, Serono/Pfizer's Rebif, Berlex/Chiron's Betaseron) or glatiramer acetate (Teva's Copaxone))無効例に限定すべきとする案には7-5、その結果relapsing MSに制限される。
Tysabri
  2006.03.07 Biogen Idec/Elan Tysabri Safety, Potential Market Re-Entry Tysabri
  2005.08.04 Pozen MT-100 Naproxen/Metoclopromide Combo For Acute Migraine MT-100
1165 2003.9.24 Forest's Memantine For Moderate-To-Severe Alzheimer's Dementia
※本剤は最初2002.7.31申請し、2002.9にいったん取下げて、2002.12.19再申請。
※有効性・安全性に対し諮問委は全員一致で承認勧告。
(Memantine)
  2003.9.25 Cephalon's Provigil To Improve Wakefulness In Sleep Disorder Patients
※2002.12申請の適応追加[不眠症に伴う過眠の改善]
※本剤は1998.12 ナルコレプシーに伴う昼間過眠で承認済み症
※審議結果として申請適応追加について4:4。 
(modafenil)
  2003.05.16 Pfizer/Eisai Aricept Vascular Dementia Indication
※2002.9.3申請。 当日の会合は委員メンバー不足によりキャンセル
 
  2002.11.18 Alzheimer's Disease Brain Imaging Trials  
1145 2001.06.6 Orphan Medical Xyrem For Cataplexy From Narcolepsy (Sodium Oxybate)承認07-17-02
  2001.03.14 Vascular Dementia Drug Trial Design  
  2001.03.13 Mild Cognitive Impairment Drug Trial Design  
  2000.01.28 Immunex Novantrone For Multiple Sclerosis  
  1999.04.28
-29
Safety and Efficacy of AggrenoxTM (Dipyridamolelaspirin)capsule [NDA 20-884]  
  1997.05.08
[pdf,449p]
NDA 20-654, MYOTROPHIN mescasermin (recombinant DNA origin) Injection for the Treatment of Amyotrophic Lateral Sclerosis
※[審査結果]6-3で MYOTROPHIN(R) (rhIGF-1 or mecasermin)注のamyotrophic lateral sclerosis (ALS or Lou Gehrig's disease)への有効性のエビデンスがないと否決。※[資料][pdf,12p-slide]
 
1004 1996.09.19 COPAXONE Cleared by FDA for Multiple Sclerosis
※[審査結果]全員一致で承認勧告
Copaxone
  1996.06.06 MYOTROPHIN for the Treatment of Amyotrophic Lateral Sclerosis[by CEPHALON]  
     
ML 開催日 議題 備考
     
 
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】Y=,N=,保留= 
 
  2016.09.14 The committees will discuss a completed postmarketing-requirement randomized, placebo controlled trial of the neuropsychiatric effects of CHANTIX (varenicline), ZYBAN (bupropion), and nicotine replacement therapy, along with relevant published observational studies to determine whether the findings support changes to product labeling.
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】Y=,N=,保留= 
varenicline/bupropion
1496 2016.03.29 The committee will discuss the specific risk-benefit profile for new drug application (NDA) 207318, NUPLAZID (pimavanserin) 17 milligram (mg) immediate-release, film-coated oral tablets, submitted by Acadia Pharmaceuticals Inc., for the proposed treatment of psychosis associated with Parkinson's disease
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[パーキンソン病に伴う精神症状への有効性]Y=12,N=2,保留=0 [安全性]Y=11,N=3,保留=0 [ベネフィットがリスクを上回るか?]Y=12,N=2,保留=0
NUPLAZID (pimavanserin)
  2016.02.03 During the morning session, the committee will discuss cognitive dysfunction in major depressive disorder (MDD). This is an evolving concept and experts in the field have not yet reached consensus as to whether cognitive dysfunction in MDD is a distinct entity. The committee will consider the clinical presentation of cognitive dysfunction in MDD, as well as methods for assessing this condition.
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】Y=,N=,保留= 
Cognitive Dysfunction in Major Depressive Disorder
  2016.02.03 During the afternoon session, the committee will discuss new drug application 204447/supplemental new drug application 006, for the effectiveness of vortioxetine for the treatment of cognitive dysfunction in MDD, submitted by Takeda Development Center Americas, Inc.
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】Y=,N=,保留= 
vortioxetine
1499 2016.01.12 The committee will discuss new drug application (NDA) 204442, PROBUPHINE (buprenorphine hydrochloride and ethylene vinyl acetate) subdermal implant, submitted by Braeburn Pharmaceuticals, Inc., on behalf of Titan Pharmaceuticals for the proposed indication of maintenance treatment of opioid dependence.
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[承認すべきか?]Y=12,N=5,保留=0 
PROBUPHINE (buprenorphine HCl/ethylene vinyl acetate)
  2015.12.01 The committee will discuss the efficacy and safety data for new drug application (NDA) 21164, gepirone hydrochloride extended-release tablets, submitted by Fabre-Kramer Pharmaceuticals, Inc., for the proposed indication of major depressive disorder.
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】Y=,N=,保留= 
gepirone
  2014.10.16 discuss the risk of serious neuropsychiatric adverse events with CHANTIX (varenicline tartrate) tablets, NDA 21928, Pfizer, Inc., and discuss options for addressing this risk.
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】Y=,N=,保留= 
varenicline
  2013.03.21 (NDA) 204442, PROBUPHINE (buprenorphine hydrochloride and ethylene vinyl acetate) subdermal implant, submitted by Titan Pharmaceuticals, Inc., and its safety and efficacy for the proposed indication of maintenance treatment of opioid dependence.
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】Y=,N=,保留= 
PROBUPHINE
1440 2011.12.12 (NDA) 022549, ADASUVE (loxapine) inhalation powder, Alexza Pharmaceuticals, Inc., for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. Particular issues for discussion are concerns regarding pulmonary safety.
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[有効性を実証したか?]Y=17,N=1,保留=0 [メーカーREMSが妥当か?]Y=1,N=17,保留=0 [FDAによるREMSが妥当か?]Y=5,N=12,保留=1 [24時間での単回投与に制限した場合、Adasuve (loxapine)吸入用粉末は、FDAによるREMSを実施するとして統合失調症および双極性躁病に伴う激越(Agitation)の治療で安全性は受容可能と結論するか?]Y=11,N=5,保留=2 [Adasuve (loxapine)吸入用粉末は、FDAによるREMSを実施し、24時間での単回投与するとして統合失調症および双極性躁病に伴う激越(Agitation)の治療で承認すべきか?]Y=9,N=8,保留=1
loxapine 
  2010.09.16 (sNDA) 21-897/015, VIVITROL (naltrexone for extended-release injectable suspension), sponsored by Alkermes, Inc., for the treatment of opioid dependence
※資料Brief Information※【審議結果】 
VIVITROL (naltrexone)
1331 2009.07.30 the safety and efficacy of new drug application (NDA) 22-117, proposed trade name, SAPHRIS (asenapine maleate) sublingual tablets, Organon, a part of Schering-Plough Corporation, for the following indications: (1) acute treatment of schizophrenia in adults; and (2) acute treatment of manic or mixed episodes of bipolar I disorder in adults
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[成人統合失調症の急性期有効性]Y=10,N=2,保留=0 [成人統合失調症の急性期安全性]Y=10,N=2,保留=0 [成人統合失調症の急性期承認可否]Y=9,N=1,保留=2 [成人双極性障害mania/mixed episodesの急性期有効性]Y=12,N=0,保留=0 [成人双極性障害mania/mixed episodesの急性期安全性]Y=12,N=0,保留=0 [成人双極性障害mania/mixed episodesの急性期承認可否]Y=12,N=0,保留=0 []Y=,N=,保留= 
SAPHRIS (asenapine maleate)
  2009.06.9-10 1) NDA 20-639/S-045 and S-046: Seroquel (quetiapine), AstraZeneca Pharmaceuticals LP, for (a) the acute treatment of schizophrenia in adolescents (13-17 years of age), and (b) the acute treatment of bipolar mania in children (10-12 years of age) and adolescents (13-17 years of age); 2) NDA 20-825/S-032: Geodon (ziprasidone), Pfizer Inc., for the acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features in children and adolescents ages 10-17 years; and 3) NDA 20-592/S-040 and S-041: Zyprexa (olanzapine), Eli Lilly and Company, for (a) the acute treatment of manic or mixed episodes associated with bipolar I disorder, and (b) the acute treatment of schizophrenia in adolescents. The committee will be asked to vote on whether or not these products have been shown to be effective and acceptably safe for these pediatric indications.
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts06.09 | Trascripts06.10※【審議結果】 
Seroquel (quetiapine)
Geodon (ziprasidone)
Zyprexa (olanzapine)
  2009.04.08 safety and efficacy issues of supplemental new drug applications (sNDAs) 22-047/S-010/S-011/S-012, Seroquel XR (quetiapine maleate), Astra Zeneca Pharmaceuticals LP, proposed for the treatment of major depressive disorder and sNDA 22-047/S-014/S-015, Seroquel XR (quetiapine maleate), Astra Zeneca Pharmaceuticals LP, proposed for the treatment of generalized anxiety disorder. Particular safety issues for discussion on April 8, 2009, regarding the Seroquel XR applications are concerns regarding exposing a greatly expanded population to a drug with known metabolic side effects and a possible risk of tardive dyskinesia.
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】 
Seroquel XR (quetiapine maleate)
  2009.04.07 (NDA) 20-644, Serdolect (sertindole) tablets, Lundbeck USA, proposed for the treatment of schizophrenia
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】 
Serdolect (sertindole)
  2008.07.10 The Peripheral and Central Nervous System Drugs Advisory Committee, the Psychopharmacologic Drugs Advisory Committee, representatives from the Pediatric Advisory Committee, and the Drug Safety and Risk Management Advisory Committee will consider the results of FDA's analysis of suicidality (both suicidal ideation and behavior) from placebo-controlled clinical studies of 11 drugs. The following drugs will be considered: (1) Carbamazepine (marketed as CARBATROL, Shire Pharmaceuticals, EQUETRO, Validus Pharmaceuticals, Inc., TEGRETOL, Tegretol XR, Novartis Pharmaceuticals Corp.); (2) felbamate (marketed as FELBATOL, Meda Pharmaceuticals, Inc.); (3) gabapentin (marketed as NEURONTIN, Pfizer, Inc.); (4) lamotrigine (marketed as LAMICTAL, GlaxoSmithKline); (5) levetiracetam (marketed as KEPPRA, UCB, Inc.); (6) oxcarbazepine (marketed as TRILEPTAL, Novartis Pharmaceuticals Corp.); (7) pregabalin (marketed as LYRICA, Pfizer Inc.); (8) tiagabine (marketed as GABITRIL, Cephalon, Inc.); (9) topiramate (marketed as TOPAMAX, Ortho-McNeil-Janssen Pharmaceuticals, Inc.,); (10) valproate (marketed as DEPAKOTE, DEPAKOTE ER, DEPAKENE, DEPACON, Abbott Laboratories); and (11) zonisamide (marketed as ZONEGRAN, Dainippon). FDA will discuss with the committee actions taken in light of the results and whether any additional actions are necessary.
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】 
 
  2008.02.06 (NDA) 22-173, ZYPREXA ADHERA (olanzapine pamoate depot) long acting intramuscular injection (210 milligrams (mg), 300 mg, and 405 mg per/vial), Eli Lilly and Co., for the treatment of schizophrenia. A particular safety concern for discussion is the occurrence of severe somnolence in some patients who are administered this depot formulation of olanzapine.
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascriptsほか※【審議結果】[統合失調症急性期の有効性]Y=11,N=0,保留=0 [統合失調症維持期の有効性]Y=11,N=0,保留=0 [統合失調症急性期の安全性]Y=10,N=0,保留=1 [統合失調症維持期の安全性]Y=10,N=0,保留=1
ZYPREXA ADHERA (olanzapine pamoate depot)
  2006.12.13 2006N-0414 Suicidality data from Adult Antidepressant Trials 
※[Brief Information](抗うつ薬による治療過程の成人の自殺問題を審議。 2004年2,9月の小児の2回の審議に続くもの。抗うつ薬372臨床試験10,000例に基づく。)
※【審議結果】1)抗うつ薬ラベル変更の必要性は8:0可決、 2)ラベル変更を黒枠警告に入れるか?は6:2可決
 
1181 2006.03.23 (NDA) 20-717, S-019, PROVIGIL (100 milligrams (mg), 200 mg, 85 mg, 170 mg, 255 mg, 340 mg, and 425 mg) Tablets, Cephalon, Inc.; the proposed indication is for the treatment of attention deficit hyperactivity disorder (ADHD).
※資料Brief Information | Slides | 議事要旨Minutes | 議事録Trascripts※【審議結果】[有効性]Y=13,N=0,保留=0 [ADHDでの安全性]Y=1,N=12,保留=0
PROVIGIL
(modafinil)
1237 2005.12.02 Shire/Noven Daytrana Methylphenidate Patch For Attention Deficit Hyperactivity Disorder
※[Brief Information]※FDA審査官Robert Levinは本剤がADHD治療上Johnson & Johnson/Alza社のConcertaよりも副作用が多い(more adverse effects)とした。“Treatment with [the methylphenidate transdermal system] was associated with a high incidence of insomnia, anorexia or decreased appetite, headache, and gastrointestinal symptoms including vomiting, nausea and upper abdominal pain,” 同審査官は不許可を提案。 本パッチは元々Noven社が2002.6.27にMethypatchの商品名で申請し、2003.4.25 "not approvable" letterを受けていた。 Shire and Novenはその後Phase II analog laboratory classroom study and a Phase III seven-week outpatient naturalistic study with shorter nine-hour wear timesを実施し、2005.6.28再申請したもの。
※【審議結果】Daytrana patchは皮膚過敏症のトラブルが懸念されるため経口薬が投与できないケースに二次選択されるべきという意見があり、添付文書で「経口投与が不可能な場合」と投与制限するという案が11−1で可決。
Daytrana
(Methylphenidate)
  2005.10.25 Need For Longer-Term Data For Proposed Psychiatric Drugs; Optimal Long-Term Study Design  
1235 2005.10.26 Somerset Emsam (Selegiline) Need For Dietary Restrictions※[Brief Information]
※抗パーキンソン病薬として販売するselegilinの新しい持続性製剤EMSAMが大うつ病の適応症で申請された。2,503症例の臨床試験とtyramine関連214症例14研究の結果が付された。MAOにより代謝される高濃度チラミンが血圧を上昇させるリスクが懸念されたためだ。 Somerset社は20mg,30mg,30mgの3製剤を申請するが、FDAは承認条件として食餌制限をつけることを主張しSomerset社は30mg,40mgについては合意していた。
※【審議結果】20mg Patch製剤はチーズや赤ワイン等高チラミン含有食餌制限をつけないことを7:4で議決。
Somerset Emsam (Selegiline)
  2004.09.14 Antidepressant Suicidality Data Review - Day 2
※自殺リスクを高めることの黒枠警告を入れることを勧告(15 vs 8)。 自殺リスクを2-3%増加させること、放置すれば15%リスク増と報告。
 
  2004.09.13 Antidepressant Suicidality Data Review - Day 1  
1176 2004.02.02 Antidepressant Risk Of Suicidality In Pediatric Patients
※2003.8にWyeth's Effexor (venalafaxine)のラベルに警告が追加。これはSSRI,norepinephrine-RIの小児臨床試験でhostility and suicide関連の副作用が発生したため。 GSK's Paxil (paroxetine)にも自殺増加のデータが発表。
※paroxetine (GlaxoSmithKline's Paxil), sertraline (Pfizer’s Zoloft), venlafaxine (Wyeth’s Effexor), and citalopram (Forest’s Celexa)について、小児自殺リスクが増加することがデータ上で明らかにされた。 Prozac (fluoxetine) については同様の兆候を示さなかった。
Effexor (venalafaxine)
  2003.06.16 Clozapine White Blood Cell Monitoring
※血液モニタリングを2週間毎から月1回に変更するとagranulocytosis(顆粒球減少症)の発生率が高まる、というのは統計的に有意でないとNovartisは報告。諮問委は追認した
(Clozapine)
  2002.11.4 Novartis Clozaril For Suicidality in Schizophrenia (Clozapine)
1199 2002.05.10 Lipha Acamprosate For Maintenance Of Alcohol Abstinence
※8/2で有効性認める|Brief Information
(Acamprosate)
承認07/29/2004
1106 2001.02.15 Pfizer Geodon IM (Formerly Zeldox) For Schizophrenia (ziprasidone HCl)
FDA承認=5-Feb-2001
0992 2001.02.14 Lilly Zyprexa Intramuscular Formulation (olanzapine)注射剤未承認
錠剤FDA承認=30-Aug-1996
1106 2000.07.19 Zeldox For Psychotic Disorders Management  
  2000.03.9 Dementia Definitions For Drug Labeling  
  開催日 議題 備考
     
  .  
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[]Y=,N=,保留= 
 
  2015.12.10 The committees will discuss the safety of codeine in children 18 years of age and younger. Codeine (most often in combination with acetaminophen) is used for the treatment of pain in children; however, it is contraindicated for the management of pain after tonsillectomy and/or adenoidectomy. Codeine (in combination with other medicines) is used for the relief of cough associated with upper respiratory allergies or the common cold in children. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[]Y=,N=,保留= 
Codeine
1497 2015.12.09 The committee will discuss biologics license application 761033, reslizumab for injection, submitted by Teva Pharmaceutical Industries, Ltd., for the proposed indication to reduce exacerbations, relieve symptoms, and improve lung function in adults and adolescents 12 years of age and above, with asthma and elevated blood eosinophils, who are inadequately controlled on inhaled corticosteroids. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[臨床効果〜18歳以上]Y=13,N=1,保留=0 [臨床効果〜12-17歳]Y=0,N=14,保留=0 [安全性]Y=11,N=3,保留=0 [承認すべきか〜18歳以上]Y=11,N=3,保留=0 [承認すべきか〜12-17歳]Y=0,N=14,保留=0 
reslizumab
1486 2015.06.11 (BLA) 125526, for mepolizumab for injection, submitted by GlaxoSmithKline for the proposed indication of add-on maintenance treatment in patients 12 years and older with severe eosinophilic asthma identified by blood eosinophils greater than or equal to 150 cells/microliter at initiation of treatment or blood eosinophils greater than or equal to 300 cells/microliter in the past 12 months. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[有効性〜18歳以上]Y=14,N=0,保留=0 [有効性〜12-17歳]Y=5,N=9,保留=0 [安全性〜18歳以上]Y=13,N=1,保留=0 [安全性〜12-17歳]Y=2,N=12,保留=0 [有効性・安全性〜18歳以上]Y=14,N=0,保留=0 [有効性・安全性〜12-17歳]Y=4,N=10,保留=0 
mepolizumab
1491 2015.05.12 (NDA) 206038, lumacaftor/ivacaftor combination tablets for oral use, submitted by Vertex Pharmaceuticals, proposed for the treatment of cystic fibrosis (CF) in patients age 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[有効性を実証したか?]Y=3,N=4,保留=6 [安全性を実証したか?]Y=13,N=0,保留=0 [有効性と安全性は承認に十分か?]Y=12,N=1,保留=0
lumacaftor/ivacaftor
  2015.03.19 (sNDA) 204275-S001, for fluticasone furoate and vilanterol inhalation powder (tradename Breo Ellipta) submitted by GlaxoSmithKline for the once daily maintenance treatment of asthma in patients 12 years of age and older. The discussion will include efficacy data, but the focus of the meeting will be safety, including the adequacy of the safety database to support approval, and whether a large safety trial to evaluate serious asthma outcomes is recommended. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[]Y=,N=,保留= 
Breo Ellipta
  2014.10.21 (sNDA) 203188, for ivacaftor oral tablets, submitted by Vertex Pharmaceuticals for the treatment of cystic fibrosis in patients 6 years and older with a R117H mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[]Y=,N=,保留= 
ivacaftor
1465 2014.08.14 (NDA) 21936, for tiotropium bromide inhalation spray, submitted by Boehringer Ingelheim Pharmaceuticals, Inc. for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) and for reducing COPD exacerbations. The discussion will include efficacy data, including the data to support the claim for reduction of COPD exacerbations, but the focus will be on safety findings from the clinical development program and the results of a large safety trial comparing tiotropium bromide inhalation spray and tiotropium bromide inhalation powder. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[有効性の実証]Y=14,N=0,保留=0 [安全性の実証]Y=9,N=4,保留=0 [承認すべきか?]Y=10,N=3,保留=0
tiotropium
  2014.02.25 The committees will discuss data submitted by Armstrong Pharmaceuticals, Inc., to support a new drug application (NDA) 205920, for over-the-counter (OTC) marketing of epinephrine inhalation aerosol 125 microgram (mcg)/actuation (proposed trade name Primatene HFA), for temporary relief of mild symptoms of intermittent asthma for consumers 12 years of age and older. The epinephrine inhaler was developed as a replacement for Primatene Mist (epinephrine metered inhaler 200 mcg/actuation), an OTC product that was phased out in December 2011 because of the use of chlorofluorocarbons as the propellant.  
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[]Y=,N=,保留= 
epinephrine吸入剤
1440 2013.09.10 (NDA) 203975 for umeclidinium and vilanterol powder for inhalation (proposed tradename Anoro Ellipta), sponsored by Glaxo Group (d/b/a/ GSK) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[効果]Y=13,N=0,保留=0 [安全性]Y=10,N=3,保留=0 [承認]Y=11,N=2,保留=0
Anoro Ellipta
1424 2013.04.17 (NDA) 204275 for fluticasone furoate and vilanterol dry powder inhaler (proposed tradename BREO ELLIPTA), sponsored by GlaxoSmithKline, for the long-term maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[効果-COPD維持療法]Y=12,N=1,保留=0 [効果-COPD悪化低減]Y=8,N=5,保留=0 [安全性]Y=10,N=3,保留=0 [承認に有効性安全性データは十分?-COPD維持療法]Y=9,N=4,保留=0 [承認に有効性安全性データは十分?-COPD悪化低減]Y=9,N=4,保留=0
BREO ELLIPTA
  2013.01.30 (NDA) 202049, for mannitol inhalation powder (proposed trade name BRONCHITOL), for oral inhalation sponsored by Pharmaxis, for the proposed indication of management of cystic fibrosis (CF) in patients aged 6 years and older to improve pulmonary function. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[効果]Y=3,N=11,保留=0 [安全性]Y=3,N=11,保留=0 [有効性と安全性総合]Y=0,N=14,保留=0
mannitol inhalation powder (BRONCHITOL)
1459 2013.01.29 (NDA) 203108, for olodaterol (proposed trade name Striverdi Respimat) metered dose inhaler, sponsored by Boehringer Ingelheim, for the proposed indication of long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[効果]Y=15,N=1,保留=1 [安全性]Y=15,N=1,保留=1 [有効性と安全性総合]Y=15,N=1,保留=1
olodaterol (Striverdi Respimat)
1405 2012.02.23 NDA 202450, for aclidinium bromide, sponsored by Forest Laboratories, for the proposed indication of long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[効果]Y=14,N=0,保留=0 [安全性]Y=10,N=3,保留=1 [有効性と安全性総合]Y=12,N=2,保留=0
aclidinium
1378 2011.06.23 (NDA) 22150, icatibant solution for injection (proposed tradename Firazyr), Shire Human Genetic Therapies, for the proposed indication of treatment of acute attacks of hereditary angioedema
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[臨床ベネフィット]Y=12,N=1,保留=0 [安全性]Y=11,N=1,保留=1 [有効性と安全性データ]Y=12,N=1,保留=0 [自己治療]Y=11,N=1,保留=1
icatibant
1389 2011.03.08 (NDA) No. 22-383, indacaterol maleate (Arcapta™ Neohaler™) by Novartis Pharmaceuticals Corporation, for the long-term once daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[有効性〜75mcg]Y=15,N=2,保留=0 [有効性〜150mcg]Y=6,N=11,保留=0 [安全性〜75mcg]Y=12,N=5,保留=0 [安全性〜150mcg]Y=11,N=6,保留=0 [QOL〜75mcg]Y=10,N=7,保留=0 [QOL〜150mcg]Y=13,N=4,保留=0 [総体的有効性・安全性〜75mcg]Y=13,N=4,保留=0 [総体的有効性・安全性〜150mcg]Y=5,N=12,保留=0
indacaterol
1369 2010.04.07 (NDA 22-522), roflumilast (DAXAS), by Forest Research Institute, for the maintenance treatment of chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis in patients at risk of exacerbations (worsening symptoms). 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[有効性]Y=9,N=6,保留=0 [安全性]Y=9,N=6,保留=0 [有効性・安全性]Y=5,N=10,保留=0(反対が多いが強くない) 
roflumilast
  2010.03.10-11 the design of medical research studies (known as “clinical trial design”) to evaluate serious asthma outcomes (such as hospitalizations, a procedure using a breathing tube known as intubation, or death) with the use of the class of asthma medications known as long acting beta-2 adrenergic agonists in the treatment of asthma in adults, adolescents, and children. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts 10日 & Transcripts 11日 | 【審議結果】[]Y=,N=,保留= 
 
1457 2010.03.09 (NDA) 22-535, pirfenidone, by InterMune. The proposed indication (purpose) of this drug is the treatment of patients with idiopathic pulmonary fibrosis (scarring of the lungs without a known cause) to decrease the decline in lung function associated with this condition. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[効果]Y=7,N=5,保留=0 [安全性]Y=9,N=3,保留=0 [承認]Y=9,N=3,保留=0
pirfenidone
  2009.11.20 (NDA) #22-368 for Aridol (mannitol bronchial challenge test), manufactured by Pharmaxis Ltd. The proposed use of this product is to assess bronchial hyperresponsiveness (airway irritability in the lungs) to aid in diagnosing patients 6 years of age or older who have symptoms of asthma or symptoms that are suggestive of asthma. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[]Y=,N=,保留= 
Aridol (mannitol bronchial challenge test)
  2009.11.19 the efficacy supplement for new drug application (NDA) No. 21-395 for the approved product Spiriva HandiHaler (tiotropium inhalation powder), manufactured by Boehringer Ingelheim for the reduction in exacerbations (worsening of symptoms) in patients with chronic obstructive pulmonary disease (COPD). 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[trials 205.235 (UPLIFT) and 205.266 (VA study)はCOPDを軽減?]Y=11,N=1,保留=0 [trial 205.235 (UPLIFT)の安全性で脳卒中の安全性を実証したか?]Y=11,N=1,保留=0 [trial 205.235 (UPLIFT)の安全性で心管系の安全性を実証したか?]Y=11,N=0,保留=1
Spiriva HandiHaler (tiotropium inhalation powder)
  2009.11.18 (BLA) # 103976, Supplement # 5149 for Xolair (omalizumab), manufactured by Genentech/Novartis. The proposed indication for this product is to treat moderate to severe persistent asthma in patients between 6 and 11 years of age whose symptoms are inadequately controlled with inhaled steroid medications and have (a) a positive reaction to skin testing with common substances that can cause allergies and asthma, such as pollen, or (b) in vitro reactivity, which is measured with a blood test that confirms the presence of specific proteins consistent with allergies and asthma. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[6-11歳の小児喘息の安全性]Y=5,N=9,保留=0 [6-11歳の小児喘息の有効性と安全性の観点から承認すべきか?]Y=4,N=10,保留=0
Xolair (omalizumab)
1345 2009.02.04 (BLA) # 125277, KALBITOR, ecallantide injection by Dyax Corp., for the proposed indication of treatment of acute attacks of hereditary angioedema. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[有効性のベネフィット;18歳以上で]Y=18,N=4,保留=1 [有効性のベネフィット;10-17歳で]Y=3,N=10,保留=0 [安全性;18歳以上で]Y=5,N=8,保留=0 [安全性;10-17歳以上で]Y=2,N=11,保留=0 [有効性と安全性の観点から承認するか]Y=6,N=5,保留=2
KALBITOR(ecallantide)
1303 2008.12.10-11 the benefit risk assessment of long acting beta-2 adrenergic agonists for the treatment of asthma in adults and children.
※Serevent(salmeterol xinafoate)/Symbicort(budesonide and formoterol)/Foradil(R)(formoterol)/Advair (fluticasone propionate; salmeterol xinafoate)※資料Briefing Information | 議事要旨Minutes | 【審議結果】※Drug Safety and Risk Management Advisory Committee (DSaRM), and Pediatric Advisory Committee (PAC)合同
 
 

12月6日のTOPICSで紹介しましたが、米FDAでは2008年12月10-11日の2日間にわたって、成人や子どもの喘息などに広く使われている長時間作用型β2刺激吸入薬(LABAs:long acting beta-2 adrenergic agonists)のリスクとベネフィットを検討を行う、肺アレルギーの薬剤諮問委員会、薬剤安全とリスクマネージメント諮問委員会、小児科の諮問委員会による合同の諮問委員会が開催されました。

 諮問委員会では、メーカーや各分野の専門家などによる意見陳述の後、LABAsを含むSerevent(セレベント)、 Foradil(本邦未発売)、Advair(アドエア)、Symbicort(本邦未発売)について、リスク・ベネフィットについての年齢ごとの評決を行いました。

 その結果、LABAs単剤のSerevent、Foradilについては喘息への使用は行わないことを勧告した一方、ステロイドとの合剤であるAdvair、Symbicortについては、ベネフィットがリスクを上回るとして、使用継続を勧告しました。(左側の数値が使用について支持。右側の数字が不支持)

Brand Name 成分 成人 12〜17歳 4〜11歳
Serevent サルメテロール 10−17 6−21 0−27
Foradil フォルモメテロール 9−18 6−21 0−27
Advair サルメテロール+フルチカゾン 27−0 23−3 13−11
Symbicort フォルモメテロール+ブテゾニド 26−1 25−2 適応承認なし

 諮問委員会では、多くの専門家から臨床上有用だとしてLABAsの販売継続を求める意見が示された他、LABAsはステロイド吸入薬との併用が勧告されているにもかかわらず、LABAs単剤のものが単独で喘息患者の半数に使用されるなど、不適切な使用が有害事象を招いたのであったとして、ステロイド合剤であるAdvair、Symbicortは使用継続するべきであるとの意見で一致したようです。

 ただ、SereventとForadilはCOPDへの適応があり、FDAが喘息への承認を取り消しても今後も市場から撤去されることはないことから、喘息に誤って使用され、今後も有害事象の発現が懸念されます。

 一方、Advairの子どもへの使用は僅差で継続が支持されました。この背景には、子どもへの成長の抑制への懸念から、コントロール改善のためにステロイド吸入剤(単剤)をむやみに増量できないことから、LABAsとの合剤でステロイドによる副作用を軽減させたいとの考えがあったのかもしれません。なお、ファーストチョイスとしては使用しないことは確認されたようです。

 今後は、「ステロイド単剤」と「ステロイド+LABAsの合剤」との間に有害事象の発現の差があるかどうかなど、LABAsそのもののリスク・ベネフィットについて、さらなる再評価が必要と思われます。

関連情報:2008.12.06 長時間作用型β2刺激吸入薬の安全性に懸念(米FDA)

 EU当局は喘息患者をリスクに直面させている。そして日本でも・・
   (薬害オンブズパーソン会議 注目情報 2008.6.20)
   http://www.yakugai.gr.jp/attention/attention.php?id=205

参考:
FDA Advisers Would End Asthma Indications for Two Long-Acting Beta2 Agonists
  (Medpage TODAY 2008.12.11)
 http://www.medpagetoday.com/AllergyImmunology/Asthma/12126
Two Asthma Meds May Be Too Risky, FDA Panel Says
  (HealthDay 2008.12.11)
 http://www.healthday.com/Article.asp?AID=622182
F.D.A. Panel Votes to Ban Asthma Drugs
  (New York Times 2008.12.11)
 http://www.nytimes.com/2008/12/12/health/policy/12fda.html

from アポネット 小嶋 FDA諮問委、LABAs単剤は喘息に使用しないよう勧告[2008.12.12]; 同様解説 セレベントなど単剤長期作動β刺激薬の喘息治療適用中止推奨 FDA委員会[2008.12.15] in 内科開業医のお勉強日記; FDA関連頁→FDA Safety Update: Asthma Medications[2008.11.18]; Advair Diskus, Advair HFA, Brovana, Foradil, Perforomist, Serevent Diskus, and Symbicort Information(Long Acting Beta Agonists)[2008.4.1];FDA/CDER による安全性に関する表示改訂(2006 年3 月分)〔米FDA][医薬品安全性情報Vol.4 No.12(2006/06/15)];(参考)小児気管支喘息の薬物療法における適正使用ガイドライン[2006.7];
  2008.02.10 中止※(NDA) 22-150, icatibant solution for injection (proposed tradename FIRAZYR), by Jerini, for the proposed indication of treatment of attacks of hereditary angioedema.  icatibant
  2007.05.01 the benefit to risk considerations for the approved product Advair Diskus 500/50 (fluticasone propionate/salmeterol inhalation powder) to increase survival and reduce exacerbations in patients with chronic obstructive pulmonary disease (COPD) (NDA 21-077 efficacy supplement). 
※Brief Information※[審議結果]1)Advair DiskusがCOPD患者の慢性治療による延命への寄与について説得力のある証拠を提供しているか? Yes=2/No=9
2)Advair DiskusがCOPD患者の慢性治療によりCOPDの悪化を臨床的に改善しているか? Yes=11/No=0
3)Advair Diskusは、COPD患者の治療にsalmeterol単独療法より実質的利点があるか? Yes=11/No=0
4)これらの研究データに観察された呼吸器感染症と肺炎の増加は、追加評価を示すか? Yes=11/No=0
Advair Diskus[GSK]
  2006.01.24 OTC Epinephrine Metered-Dose Inhaler Essential Use Of CFC Propellants
※Brief Information※[審議結果]
 
  2005.07.14 Essential Use Designations For Asthma & COPD Therapies
Azmacort, Alupent, Intalが"Essential" Drugsの地位に留まるかの審議※Brief Information※[審議結果]諮問委は7品目を審議、Boehringer Ingelheim's Alupent (metaproterenol), 3M's Maxair (pirbuterol), Forest's Aerobid (flunisolide), Kos' Azmacort (triamcinolone), King's Intal (cromolyn), Tilade (nedocromil), and Combivent。 最後のCombivent (albuterol/ipratropium)は5-5で評決が別れた。
 
  2005.07.13 Long-Acting Beta-Agonist Safety Data
GSK's Serevent (salmeterol), Advair (fluticasone propionate/salmeterol) and Novartis' Foradil (formoterol)の3品目を市場回収すべきかが審議。※Brief Information※[審議結果]Foradilは黒枠警告を表示。 Sereventは"could be a class effect"。
  2005.06.06 Chiron Pulminiq For Lung Transplant Rejection
肺移植での免疫抑制剤、承認されれば、この適応では初の薬剤。※Brief Information※[審議結果]8-8で評決は別れた。延命効果について疑問視する声も多かったということ。
Pulminiq(ciclosporinエアゾール)
  2004.06.10 Albuterol MDI Essential Use Exemption Removal
※chloroflurocarbons[CFC]等のオゾン消費推進剤を使用しないようにする審議。 現在CFC-free albuterol inhalersは2種類で、Ventolin HFA[GSK] and Proventil HFA[Schering-Plough]。 CFC含有アルブテロールのジェネリック剤が市場の90%を占める。
※Brief Information | Slide[ppt,31p](CFC問題の規制、関連製品の切換状況、問題点等の優れた報告書)
(Albuterol)
  2003.9.5 GlaxoSmithKline Ariflo For COPD
※2002.12申請、欧州は2004申請予定。phosphodiesterase-4 inhibitor。
※効果の大きさと確実性が不十分との結論[7-3]で、長期試験の追加を要請
(cilomilast)
1163 2003.05.15 Genentech/Novartis/Tanox Xolair Will Be Considered For Allergic Asthma
※(中・重症)アレルギー喘息を適応とする初の生物製剤。Genentechが2000.6申請、2002.12 Genentech/Novartis両社がUser Fee利用で申請修正
※結果は(11-0)で承認勧告
(omalizumab)
1183 2002.09.6 Boehringer-Ingelheim/Pfizer Spiriva Review
※当初喘息薬として開発されていたが効果が乏しく開発を中断していた気管支拡張剤で、COPD治療薬として2001.12.13 FDA申請。本諮問委では承認勧告。しかしCOPDに伴うDyspnea(呼吸困難)は否認。 ベーリンガー社開発品で欧州では発売
(tiotropium)
1147 2002.04.22 Schering-Plough Claritin Rx-to-OTC Switch Applications (loratadine)
  2002.01.17 Flovent/Advair Review For COPD Flovent[Pfizer](Fluticasone Propionate)
Advair[GSK](Fluticasone Propionate/Salmeterol Xinafoate)
  2001.05.11 Allegra, Claritin, Zyrtec OTC Switch
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts[rtf]  
 
  1999.11.23 Glaxo Wellcome, Inc., NDA 21-077, Advair Diskus (three strengths) for the maintenance treatment of asthma as a prophylactic therapy in patients 12 years of age and older
※議事録Transcripts[pdf] | Transcripts[rtf]  
Advair Diskus
  1999.11.22 the phaseout of CFCs in metered-dose inhalers
※議事録Transcripts[pdf] | Transcripts[rtf]  
CFCs
  1998.07.30 Orally Inhaled/Intranasal Corticosteroids and Growth in Children
※ | 議事録Transcripts1[pdf] | Transcripts1[rtf]   | Transcripts2[pdf] | Transcripts2[rtf] 
 
  1997.12.15 NDA 20-793, Cafcit (caffeine citrate injection) for Intravenous or Oral Use in the Treatment of Apnea of Prematurity
※議事録Transcripts[pdf] | Transcripts[rtf]
caffeine citrate
  1997.04.11 to discuss how the FDA should come into compliance with the medical uses of CFCs.
※議事録Transcripts[pdf]  Transcripts[rtf]
CFCs
  開催日 議題 備考
     
  2016.  
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[]Y=,N=,保留=
 
1478 2015.06.04 (NDA) 022526, flibanserin 100 milligram (mg) tablets, submitted by Sprout Pharmaceuticals Inc., proposed for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[ベネフィットがリスクを上回るか?]Y=18,N=6,保留=0
flibanserin
  2014.12.18 the meeting will be closed to permit discussion of whether FDA should permit further clinical development of an existing investigational drug product, which will include the review of trade secret and/or confidential information   
  2014.09.18 (NDA) 206089, (oral testosterone undecanoate tablets), submitted by Clarus Therapeutics, for the proposed indication of testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[]Y=,N=,保留=
testosterone undecanoate
  2014.09.17 The committees will discuss the appropriate indicated population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes associated with this use. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[]Y=,N=,保留=
testosterone replacement therapy
1439 2013.04.18 (NDA) 22219, AVEED (testosterone undecanoate) intramuscular injection, submitted by Endo Pharmaceutical Solutions, Inc., for the proposed indication of replacement therapy in adult males for conditions associated with a deficiency or absence of testosterone. The safety discussion will focus on postmarketing reports of oil microembolism in the lungs and potential anaphylactic reactions. In addition to AVEED, other approved testosterone injectable products will be referenced, especially in regard to oil microembolism and potential anaphylactic reactions reported for those products. 
※資料Briefing Information | Slides | 議事要旨Minutes | | 【審議結果】[安全性は十分か?]Y=9,N=9,保留=0 [本剤は緩徐な速度(30-60秒)で筋注する。注射後30分間医院内に滞在することは、重篤な注射反応リスクを回避するのに十分か?]Y=1,N=17,保留=0
AVEED (testosterone undecanoate) intramuscular injection
  2013.03.05 discuss whether the benefit of calcitonin salmon for the treatment of postmenopausal osteoporosis (thinning and weakening of bones that increases the chance of having a broken bone) outweighs a potential risk of cancer. Calcitonin salmon products approved for the treatment of osteoporosis include Miacalcin (calcitonin salmon) injection and nasal spray, submitted by Novartis Pharmaceuticals Corporation; Fortical (calcitonin salmon recombinant) nasal spray, Upsher Smith Laboratories; and the generic equivalents of these products. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[]Y=,N=,保留=
calcitonin salmon
  2013.03.04 (NDA) 022506, gabapentin 600 milligram (mg) tablets, submitted by Depomed, Inc., for the proposed indication of treatment of moderate to severe vasomotor symptoms due to menopause.
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[有効性のエビデンスは十分?]Y=1,N=13,保留=0 [ベネフィット/リスクから承認すべきか?]Y=2,N=12,保留=0
gabapentin
1428 2013.03.04 NDA 204516, paroxetine mesylate 7.5 mg capsules, submitted by Noven Therapeutics, LLC, for the proposed indication of treatment of moderate to severe vasomotor symptoms associated with menopause.
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[有効性のエビデンスは十分?]Y=7,N=7,保留=0 [臨床的に有用か?]Y=4,N=10,保留=0 [ベネフィット/リスクから承認すべきか?]Y=4,N=10,保留=0
paroxetine mesylate
1410 2012.04.05 the benefits and risks of mirabegron (YM178), under New Drug Application (NDA) 202611, submitted by Astellas Pharma Global Development Inc. for the proposed indication of treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Mirabegron is a beta-3-adrenoceptor (AR) agonist and is a new molecular entity. The benefit/risk discussion will focus on the adequacy of the demonstration of efficacy and safety in the treatment of OAB 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[OABへのベネフィットの実証はあるか?]Y=8,N=4,保留=0 [安全性は?]Y=9,N=3,保留=0 [承認を支持するか?]Y=7,N=4,保留=1
mirabegron
  2012.01.20 (NDA) 22-139, progesterone gel 8%, Columbia Laboratories, Inc., for the proposed indication of "reduction of risk of preterm birth in women with short uterine cervical length regardless of other risk factors in the mid-trimester of pregnancy.” The uterine cervix is the mouth of the uterus (or womb) leading into the vagina (or birth canal). The benefit/risk discussion will focus on the adequacy of the demonstration of efficacy in the US population. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[]Y=,N=,保留=
progesterone gel
1478 2011.6.18 (NDA) 22-526, flibanserin 100 milligram (mg) tablets, by Boehringer Ingelheim Pharmaceuticals, Inc., for the proposed indication of the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women.
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】eDiaryを用いた二つの臨床試験で性的欲求エンドポイントでの有効性を示さなかった。[a)28日リコールを用いたFSFI (Female Sexual Function Index)で評価したほうが良いか?]Y=2,N=9,保留=0 [性的欲求測定方法を変更するのが適当か?]Y=2,N=9,保留=0 [プラセボに対し有効性を実証したか?]Y=1,N=10,保留=0 [有効性と安全性を考慮して、ベネフィットがリスクを上回るか?]Y=0,N=11,保留=0
flibanserin
  2011.6.17 (NDA) 22-474, ulipristal acetate tablets, 30 milligrams (mg), by Laboratoire HRA Pharma. Ulipristal is an emergency contraceptive for the proposed indication of the prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[]Y=,N=,保留= 
ulipristal  
1478 2010.06.18 (NDA) 22-526, flibanserin 100 milligram (mg) tablets, by Boehringer Ingelheim Pharmaceuticals, Inc., for the proposed indication of the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】eDiaryを用いた二つの臨床試験で性的欲求エンドポイントでの有効性を示さなかった。[a)28日リコールを用いたFSFI (Female Sexual Function Index)で評価したほうが良いか?]Y=2,N=9,保留=0 [性的欲求測定方法を変更するのが適当か?]Y=2,N=9,保留=0 [プラセボに対し有効性を実証したか?]Y=1,N=10,保留=0 [有効性と安全性を考慮して、ベネフィットがリスクを上回るか?]Y=0,N=11,保留=0
flibanserin
1355 2010.06.17 (NDA) 22-474, ulipristal acetate tablets, 30 milligrams (mg), by Laboratoire HRA Pharma. Ulipristal is an emergency contraceptive for the proposed indication of the prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[有効性のデータは十分か?]Y=11,N=0,保留=0 [安全性のデータは十分か?]Y=11,N=0,保留=0 [特定の利用者への使用上の注意が必要か? 例体重の重い人への効果が減じるのでBMIが30Kg/m2超とか]Y=5,N=6,保留=0 [添付文書と医療従事者向け教育以外に何か必要か?]Y=0,N=11,保留=0
ulipristal
1349 2009.08.13 PROLIA (denosumab)[Amgen Inc]for the prevention and treatment of postmenopausal osteoporosis and the prevention and treatment of bone loss in patients undergoing hormone ablation for either prostate cancer or breast cancer. (閉経後骨粗鬆症の予防と治療、および前立腺癌または乳癌でホルモン除去療法を受けている患者の骨損失の予防と治療)
※資料Briefing Information | Slides | 議事録Transcripts | ニュース【審議結果】4つの適応のうち乳癌を除く3つに承認勧告
PROLIA (denosumab)
  2008.09.08 NDA 22-242,FABLYN (lasofoxifene tartrate) Tablets, 0.5mg, Pfizer Inc.,閉経後骨粗鬆症
※資料Briefing Information | 議事要旨Minutes | 【審議結果】[Q1a]全死亡例とlasofoxifene治療例の死亡率増加と関連あるか?〜Y=2,N=4,決定不可=7 [Q2]lasofoxifeneの静脈血栓イベントの安全性が既存薬より高いか〜Y=2,N=9,決定不可=2 [Q4a]lasofoxifeneのベネフィットはリスクを上回るか?〜Y=9,N=3,保留=1
FABLYN (lasofoxifene tartrate)
  2007.01.23 Current issues which influence the consideration for approval of oral and non-oral (i.e., transdermal and intravaginal) hormonal contraceptive drug products.※1)臨床研究デザイン、2)有効性・安全性アウトカム、3)Translation、4)周期制御を論議
※資料(23-24)Brief Information
※議事要旨(23-24)Minutes〜[16. 低用量ピルを高用量ピルよりも静脈血栓リスクを低減したものとしてFDAは承認すべきか?(例:20μgエストロゲン vs 30-35μgエストロゲン)]諮問委の意見はYes
 
  2007.01.24 Current issues which influence the consideration for approval of oral and non-oral (i.e., transdermal and intravaginal) hormonal contraceptive drug products.※4)周期制御(継続)、5)Extended Dosing Regimens、6)Phase 4 commitments、7)ラベリング  
1364 2006.08.29 早産防止薬17 alpha-hydroxyprogesterone caproate injection(Gestiva[Adeza Biomedical]) 
※Brief Information | Slides | 議事要旨Minutes | 議事録Transcripts | 【審議結果】[Q1a)17P-CT-002研究のエンドポイントで、37週以下の早産予防で死亡率低減のサロゲートは十分か?]Y=5,N=16,保留=0 [1b)違う場合、35週以下の早産予防でサロゲートは十分か?]Y=13,N=8,保留=0 [1c)違う場合、32週以下の早産予防でサロゲートは十分か?]Y=20,N=1,保留=0 [Q2)17P-CT-002研究で37週以下の早産発生率が対照群55%、Maternal Fetal Medicine Units Network trial 37%、17P-IF-001研究36%。17P-CT-002の知見をreplicateする必要は?]Y=9,N=12,保留=0 [Q3a)17OHP-Cは35週以前の早産予防のエビデンスを示したか?]Y=12,N=9,保留=0 [Q3b)17OHP-Cは32週以前の早産予防のエビデンスを示したか?]Y=7,N=14,保留=0 [Q3c)17OHP-Cは死亡率低減のエビデンスを示したか?]Y=2,N=19,保留=0 [Q4a)17OHP-Cはsecond trimester miscarriage and stillbirthのリスク増加を評価する追加試験が必要か?]Y=21,N=0,保留=0 [Q3b)もしそうなら、承認前または市販後にその情報を獲得すべき?]承認前=8,市販後=13,保留=0 [Q5)Studies 17P-CT-002 and 17P-IF-001 and Study 17P-FU (long-term follow-up)で得られた安全性データは、十分か?]Y=13,N=8,保留=0 [Q6)市販後の追加臨床試験は必要か?]Y=21,N=0,保留=0 
17 alpha-hydroxyprogesterone caproate injection(Gestiva[Adeza Biomedical])
  2004.12.02 P&G Intrinsa For Female Sexual Dysfunction
※更年期女性の性欲減退の治療薬として審議される。 今年夏に申請され、User Feeによる優先審議事項。 本剤はP&GがTheraTech,現Watsonからライセンスを受けたもの。 対象患者数は約4000万人の女性。 臨床試験結果では、性欲増加50%前後、性的満足度増加74%,51%

Intrinsa(testosterone transdermal patch)
1177 2003.12.15 Folic Acid/Oral Contraceptive Combination Product
※経口避妊薬[OC]は葉酸濃度を低下させるが、これは新生児の神経管損傷リスクを伴う。 そのために神経管閉鎖障害を防ぐ葉酸をあらかじめ配合したOCの承認を審議。
※[審議結果]承認は妥当との結果。 安全性に問題なしとの意見が11:7※Brief Information
OC/葉酸400mcg配合剤(J&J's Ortho-McNeil Pharm)
1175 2003.12.16 Plan B Emergency Contraceptive OTC Switch
※WCCは2003.4.21に39施設11,000 人の臨床データを提出してNDA申請。 販売元となるBarr社は患者教育のためCARE[Convenient Access, Responsible Education]プログラムを準備している。 尚Plan Bは性交後3日以内にlevonorgestrel 75mgを2回(12時間おきに)服用することで緊急避妊する経口剤。 Rx用に1999.7市販されていたものをOTCとして申請したもの※トピックOTC Emergency Contraceptive Application Nearing Advisory Committee Review
※[審議結果]22:5で承認勧告※[諮問委資料]
PlanB[Women's Capital Corp]
(levonorgestrel)
  2003.9.29 Infertility Drug Clinical Trial Design And Outcome Measures[排卵誘発剤]
※不妊症薬[Infertility Drug]治験のprimary endpointは卵胞刺激[follicular stmulation]よりも臨床的妊娠である。したがってその指標としての胎児心拍数[fetal heartbeat]と胎嚢[gestational sac]の測定が重要との結論。これはFDA draft guidanceに反映される
※Brief Information
 
  2003.9.30 Serono Luveris For Induction Of Ovulation In Infertile Women
※[排卵誘発剤]EU 2000.11承認済み
※Serono社はthe recombinant follicle stimulating hormone agent Gonal-Fとの併用投与の予定
※[審議結果]データは十分として承認勧告11-3。 Brief Information
Luveris[Serono]
(lutropin alpha for inj.)
  2000.09.12 Rx Drug Therapy In Nursing Mothers  
  2000.04.10 TAP Uprima Committee Review  
  2000.03.29 Pregnancy Labeling Changes, Registries - Day 2  
  2000.03.28 Pregnancy Labeling Changes, Registries - Day 1  
ML 開催日 議題 備考
     
  2015.11.13 The committee will meet in open session to discuss considerations for evaluation of the safety and effectiveness of vaccines administered to pregnant women to protect the infant. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留=
 
1486 2015.09.15 The committee will meet in open session to discuss and make recommendations on the safety and immunogenicity of Seasonal Trivalent Influenza Vaccine, Surface Antigen, Inactivated, Adjuvanted with MF59 (FLUAD) manufactured by Novartis. 
※資料Briefing Information: FDA- FLUAD - Briefing Information: Sponsor- FLUAD - Briefing Information Errata: Sponsor- FLUAD| Slides | 議事要旨Minutes | 議事録Transcript | 【審議結果】[有効性]Y=11,N=1,保留=1 [安全性]Y=10,N=2,保留=1
FLUAD
  2015.05.12 The committee will meet in open session to discuss the development and licensure of Ebola vaccines. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留=
Ebola vaccines
  2015.03.04 The committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2015-2016 influenza season. 
※資料Briefing Information1 - Briefing Information2 - Briefing Information3 - Briefing Information4| Slides | 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留=
influenza virus vaccines
  2014.03.20 to hear updates of the research programs in the Laboratory of Respiratory and Special Pathogens, Division of Bacterial, Parasitic and Allergenic Products, and in the Laboratory of Hepatitis Viruses, Division of Viral Products, Center for Biologics Evaluation and Research, FDA. 
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留=
 
  2014.02.28 to hear an overview of the research program in the Laboratory of Respiratory Viral Diseases, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. The committee will then discuss and make recommendations on the selection of strains to be included in the influenza virus vaccine for the 2014 to 2015 influenza season. 
※資料Presentations | 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留=
 
  2013.11.13 to hear an overview of the research programs in the Laboratory of Retrovirus Research and the Laboratory of Immunoregulation, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA.
※議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留= 
 
  2013.05.08 to hear an overview of the research program in the Laboratory of DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA.
※資料 | 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留= 
 
  2013.02.27 to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccine for the 2013-2014 influenza season.
※資料| Slides | 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留= 
 
  2012.11.15 to discuss and make recommendations on the safety and efficacy of a Hepatitis B Vaccine manufactured by Dynavax
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留= 
Hepatitis B Vaccine
  2012.11.14 to discuss and make recommendations on the safety and immunogenicity of an Influenza A (H5N1) Virus Monovalent Vaccine manufactured by GlaxoSmithKline
※資料Briefing Information1 | Briefing Information2 | Slides | 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留= 
Q-Pan H5N1
  2012.09.19 to discuss consideration of the appropriateness of cell lines derived from human tumors for vaccine manufacture
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留= 
 
  2012.02.29 Licensure Pathways for Pandemic Influenza Vaccines
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留= 
 
  2012.02.28 Presentation of Laboratory of Mycobacterial Diseases & Cellular Immunology (LMDCI), Division of Bacterial, Parasitic, & Allergenic Products (DBPAP), Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER)
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留= 
 
  2011.11.16 to hear an overview of the research program in the Laboratory of Method Development, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留= 
 
  2011.11.16 an update on the evaluation of Gullian-Barre Syndrome after Influenza Vaccine among Medicare population, 2010-2011
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留= 
 
  2011.11.16 discuss and make recommendations on the safety and immunogenicity (surrogate endpoint) of Pneumococcal 13-valent conjugate vaccine (Diphtheria CRM197 Protein) in adults aged 50 years and older using an accelerated approval regulatory pathway.
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留= 
 
  2011.09.20 Presentation of Laboratory of Enteric and Sexually Transmitted Diseases, Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research
※資料 | 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留= 
 
  2011.04.06 the use of immunological markers for demonstration of effectiveness of meningococcal serogroups A,C,Y and W-135 conjugate vaccines administered to children less than 2 years of age
※資料Briefing Information | Briefing Information2 | Slides | 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留= 
meningococcal serogroups A,C,Y and W-135 conjugate vaccines[Pfizer]
1431 2011.04.07 meningococcal serogroup B vaccines
※資料Briefing Information | Briefing Information2 | Slides | 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留= 
Meningococcal B Vaccine(4CMenB)[Novartis]
  2011.02.25 make recommendations on the selection of strains to be included in the influenza virus vaccine for the 2011-2012 influenza season
※資料| Slides | 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留= 
 
  2010.11.17 review and discuss the effectiveness of vaccinating males and females with Gardasil manufactured by Merck & Co. for the prevention of anal dysplasia and anal cancer
※資料Briefing Information1 | Briefing Information2 | 【審議結果】[]Y=,N=,保留= 
Gardasil[Anal Cancer]
  2010.11.16 review and discuss the pathway to licensure for protective antigen-based anthrax vaccines for a post-exposure prophylaxis indication using the animal rule.
※資料Briefing Information1 | Briefing Information2 | 【審議結果】[]Y=,N=,保留= 
anthrax vaccines
  2010.09.21 updates on the research programs of the Laboratory of Respiratory & Special Pathogens, Division of Bacterial, Parasitic, & Allergenic Products; Laboratory of Hepatitis Viruses, and Laboratory of Vector Borne Virus Diseases, Division of Viral Products, Office of Vaccines Research and Review, CBER, FDA.
※資料| 【審議結果】[]Y=,N=,保留= 
 
  2010.05.07 review and discuss available data regarding the unexpected finding of DNA originating from porcine circovirus type 1 (PCV 1) in Rotarix, a U.S. licensed vaccine manufactured by GlaxoSmithKline and indicated for the prevention of rotavirus gastroenteritis in infants. The committee will discuss what additional steps should be considered to address this finding. In the afternoon, the committee will discuss and make recommendations on the use of advanced analytical detection methods not currently applied for the characterization of cell substrates, viral seeds, and other biological materials used in the production of viral vaccines for human use.
※資料Briefing Information | Presentations | Background Material Porcine Circovirus and Rotavirus Vaccines | 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留= 
Rotarix
  2010.02.20 recommendations on the selection of strains to be included in the influenza virus vaccine for the 2010-2011 influenza season
※資料 | 議事録Transcript | 【審議結果】[]Y=,N=,保留= 
influenza virus vaccine
  2009.12.15 updates of the research programs in the Laboratory of Retroviruses, Laboratory of Immunoregulation, and Laboratory of Respiratory Viruses, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA.
※資料| Presentations | 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留= 
 
1409 2009.11.19 recommendations on the safety and effectiveness of an Influenza Vaccine, Purified Recombinant Influenza Hemagglutinin, BLA STN125285
※資料Briefing Information | 議事要旨Minutes | 議事録Transcript | 【審議結果】[有効性18-49歳]Y=9,N=2,保留=0 [有効性50-64歳]Y=5,N=6,保留=0 [有効性65歳以上]Y=2,N=9,保留=0 [安全性18歳以上]Y=5,N=6,保留=0
Flublok(Influenza Vaccine)
1345 2009.11.18 on the safety and effectiveness of a Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein), BLA125324[Prevnar 13]
※資料Briefing Information| 議事要旨Minutes | 議事録Transcript | 【審議結果】[有効性データは十分か?]Y=10,N=1,保留=0 [安全性データは十分か?]Y=10,N=1,保留=0 
Prevnar 13
  2009.11.18 an update on FDA’s Influenza A (H1N1) 2009 monovalent vaccine activities
※資料| 議事要旨Minutes | 議事録Transcript | 【審議結果】[]Y=,N=,保留= 
Influenza A (H1N1) 2009 monovalent vaccine
1338 2009.09.09 Human Papillomavirus vaccine(CERVARIX)[GSK]の女性への有効性と安全性 
※資料Briefing Information | Presentations | 議事録Transcript | 【審議結果】承認勧告(有効性:賛成12、反対1、安全性:賛成11、反対1)
CERVARIX
  2009.07.23 2009 H1N1 influenza virus vaccine 
※資料Briefing Information | Presentations | 議事録Transcript | 【審議結果】
influenza vaccine
  2009.02.18-19 influenza virus vaccine for the 2009 - 2010 
※資料Briefing Information | 議事要旨Minutes | 【審議結果】
influenza vaccine
  2008.11.20 April 3, 2008 site visit of the intramural research programs of the Laboratory of DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER). 
※Slides | 議事要旨Minutes | 【審議結果】
 
  2008.09.25 VRBPAC Meeting; Use of MDCK Cells for Manufacture of Live Attenuated Influenza Virus Vaccines by MedImmune 
※資料Briefing Information | Slides | 議事要旨Minutes | 【審議結果】
influenza vaccine
  2008.02.21 selection of strains to be included in the influenza vaccine for the 2008--2009 influenza season 
※資料Briefing Information | Slides | 議事要旨Minutes | 【審議結果】
influenza vaccine
  2008.02.20 Rotarix,a rotavirus vaccine by GlaxoSmithKline  
※資料Briefing Information | Slides | 議事要旨Minutes | 【審議結果】
Rotarix
  2007.11.14 研究プログラム進捗状況(1) The Laboratory of Method Development, Division of Viral Products, Center for Biologics Evaluation and Research, FDA and (2) the Laboratory of Mycobacterial Diseases & Cellular Immunology, Division of Bacterial Parasitic & Allergenic Products, Center for Biologics Evaluation and Research, FDA 
※資料Slides | 議事要旨Minutes | 【審議結果】
 
  2007.05.17 influenza virus vaccine live (FluMist)by MedImmune Vaccines, Inc.
※資料Briefing Information | Slides | 議事要旨Minutes | 【審議結果】benefits/risk;Y=15,N=0,保留=0
FluMist
  2007.05.16 a live vaccinia virus smallpox vaccine (ACAM2000) by Acambis, Inc 
※資料Briefing Information | Slides | 議事要旨Minutes | 【審議結果】[有効性]Y=11,N=0,保留=0 [安全性]Y=11,N=0,保留=0 [RiskMAP]Y=10,N=1,保留=0 
ACAM2000
  2007.02.28 influenza virus vaccine for the 2007-2008 season. 
※資料Briefing Information - Briefing 2 | Slides | 議事要旨Minutes | 【審議結果】
influenza vaccine
  2007.02.27 an H5N1 inactivated influenza vaccine by Sanofi Pasteur 
※資料Briefing Information | Slieds | 議事要旨Minutes | 【審議結果】
 
  2007.01.25 PENTACEL (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib)), manufactured by Sanofi Pasteur, Ltd 
※資料Briefing Information | Slides | 議事要旨Minutes | 【審議結果】
PENTACEL/DTaP-IPV/Hib
  2006.11.16 ラボ監査報告とヒアリング | 議事要旨Minutes  
  2006.05.19 Research Program At CBER Office of Vaccines Research and Review (Research Review Subcommittee)  
1241-2 2006.05.18 Merck Gardasil Human Papillomavirus Vaccine ※FDAの指摘する問題点としては、まず以前HPVに感染した患者での有効性データが欠如。 次にGardasilがHPV感染患者のcervical diseaseを亢進させる可能性。 また接種患者に5例の先天異常出産が報告。※Brief information | Slides | 議事要旨Minutes | 議事録Transcript | ※【審議結果】[有効性]Y=13,N=0,保留=0 [免疫原性データは十分か]Y=13,N=0,保留=0 [安全性]Y=13,N=0,保留=0 Gardasil(HPV Vaccine)
  2006.02.17 Influenza Vaccine Strain Selection For 2006-2007 Flu Season  
1243 2005.12.15 Merck's Zostavax Live Zoster Vaccine ※本剤は現在chickenpox予防でVarivaxとして市販されているthe live varicella zoster vaccine (Oka/Merck)を更に強力にしたもの。 60才以上の健常人38,500例のピポタル研究で3年後herpes zoster発生率を51.3%低減、post-herpetic neuralgia 発生率は66.5%低減。※Brief information※【審議結果】60才以上の水痘治療に有効かつ安全と結論。 Zostavax
1240 2005.12.14 Merck's Rotateq Rotavirus Vaccine ※P3研究で腸重積intussusception(bowel obstruction) 6例の報告あり(Placebo 5例)。ちなみにRotaShield(Wyeth)は1999年colon disorderの報告で販売中止している。※Brief information※【審議結果】腸重積リスクの安全性データを再確認すべきという意見も出たが、安全性および有効性についてそれぞれ全員一致で賛成。 Rotateq(Rotavirus Vaccine)
  2005.11.17 Development Of New Pneumococcal Vaccines For Adults; Pneumovax 23[Merck & Co]
※資料Briefing Information | Slides | 議事要旨Minutes | 【審議結果】
Pneumovax 23/
  2005.11.16 Influenza Vaccine Manufacturing With Canine Kidney Cells  
  2005.03.15 GSK Boostrix, Sanofi-Aventis Adacel Tdap Vaccines※破傷風・ジフテリア・無細胞百日咳ブースターワクチンtetanus/diphtheria/acellular pertussis booster vaccines
※[審査結果]Boostrix[GSK],Adacel[Sanofi-Aventis]両ワクチンの有効性と安全性については13-0で全員承認。しかし小児期に無細胞百日咳ワクチン接種をうけた患者へのTdapワクチン接種への懸念がある。 本臨床試験の小児は全細胞ワクチン接種を受けているが、米国では既に全細胞ワクチン接種は実施されていない。 また現在米国で小児・成人向けの百日咳ワクチンは販売されていない。 Boostrixは10-18才,Adacelは11-64才への適応を求めていた。>※[Brief Information]
Boostrix[GSK]
Adacel[Sanofi-Aventis]
  2005.02.17 FDA Critical Path Initiative; CBER Research Programs  
  2005.02.16 Influenza Vaccine Strain Selection For 2005-2006 Season  
  2004.09.23 Aventis Pasteur/VaxGen AIDS Vaccine Phase III Trial
※AIDS vaccine combines Sanofi-Aventis' HIV-1 recombinant canarypox-vectored vaccine (ALVAC vCP1521) and VaxGen's recombinant gp120 B/E (CHO cells) with alum.
※[審議結果]米軍によるタイでの5600人のP3臨床試験RV144は効果に乏しい結果に終わった。FDA briefing documents
 
1206 2004.09.22 Aventis Menactra Meningococcal Vaccine
※[審議結果]Menomuneとのimmunogenicity and safetyに関する比較で、Menactraは劣るものではないと意見で一致した。患者血清群に対する抗体反応は、小児ではMenomune 80-95%,Menactra 82-97%、成人ではMenomune 80-94%,Menactra 74-89%。 諮問委は長期間の効果試験と承認後の安全性試験を勧告。briefing document
Menactra
  2004.02.18 Selection Of Strains For 2004-2005 Flu Vaccine - Day 1
※前期2003-2004では反省点があった。 実際に流行したH3N2 Fujianはワクチンに含まれなかった。 2003.2のFDA/CDC合同会議でその前のH3N2株であるA/Panama/2007/99が無効だったという報告がなされたにも関わらず、2003-2004期でも選択された。
 
  2004.02.19 Selection Of Strains For 2004-2005 Flu Vaccine - Day 2
※[審議結果]2004-2005ワクチンはVictoria (B/Hong Kong/330/01-like)株を含有していたが、FDA諮問委は一致してVictoria株からYamagata lineageへの変更を推奨。 結果として、インフルエンザB株については、3月17日の電話会議で決めることとなった。
 
  2003.05.09 intramural research programs of several CBER laboratories  
  2003.03.18 Selection of Strains for 2003-2004 Influenza Vaccine
※Brief Information
 
  2003.02.20 Selection of Strains for 2003-2004 Influenza Vaccine
※influenza A H1N1 and influenza B菌株は前シーズンと同じ。3番目菌株influenza A H3N2は3月半ばまで様子見
※Brief Information
 
1163 2002.12.17 MedImmune FluMist Second Review For Influenza
※50-64才の有効性データが更に必要との結論
5-49才での有効性は14:4、安全性は5-49才17:1、50-64才10:8
インフルエンザA,B予防経鼻ワクチン
1153
1074
2002.05.21 Wyeth Prevnar For Otitis Media
※資料Briefing Information | Slides | 議事要旨Minutes | 議事録Transcript | 【審議結果】急性中耳炎の効果を認める
(pneumococcal vaccine肺炎球菌ワクチン)
FDA承認=17-Feb-2000
  2002.03.06 WHO Recommendations for the Influenza Virus Vaccines for the 2002-2003 Season
※Brief Information
 
  2002.01.30 Influenza Vaccine Formulation For 2002-2003 Flu Season  
  2001.11.29 Human Papilloma Virus Vaccine Development - Day 2  
  2001.11.28 Human Papilloma Virus Vaccine Development - Day 1  
1163 2001.07.27 Aviron FluMist Intranasal Flu Vaccine Review - Day 2  
1163 2001.07.26 Aviron FluMist Intranasal Flu Vaccine Review - Day 1  
  2001.05.16 Viral Vaccine Manufacturing Discussion  
  2001.03.9 Influenza Vaccine Formulation For 2001-2002 Flu Season  
1074 2001.03.8 Pneumococcal Conjugate Vaccine Development
※資料Briefing Information | 議事録Transcript | 【審議結果】
Prevnar肺炎球菌ワクチン
  2001.03.7 GlaxoSmithKline Infanrix Safety, Immunogenicity Data Review DTPワクチン
FDA承認=29-Jan-1997
1049 2001.01.31 GlaxoSmithKline Lymerix Postmarketing Safety Review ライム病ワクチン
FDA承認=21-Dec-1998 
  2001.01.30 Influenza Vaccine Formulation For 2001-2002 Flu Season  
  2000.11.3 TSE Update  
  2000.11.3 Aventis Tripacel DTaP Vaccine Review DTPワクチン
  2000.05.12 Vaccine Manufacturing With Neoplastic Cells  
1053 2000.05.11 Rotavirus Vaccine Status  
  2000.01.28 Influenza Vaccine Formulation For 2000-2001 Flu Season  
  2000.01.27 Haemophilus Influenza Type B Combination Vaccines  

Source: http://www.medmk.com/mm/add/fda_advisory_committee.htm


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