Briefing Materials - FDA

Disclaimer: Portions of these documents have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. Sec. 552).

• Cover Memo (December 8, 2009) (PDF - 24KB)
• Additional Reference Information
• Safety Monitoring of Drugs Receiving Pediatric Marketing Exclusivity
• Abilify: Safety Review (PDF - 556KB)
• 021436S017_Aripiprazole_Clinical_BPCA.pdf (PDF - 1.7MB)
  Abilify: Clinical Review Summary of Pediatric Studies
• 021436S017_Aripiprazole_Clinpharm_BPCA.pdf (PDF - 3.6MB)
  Abilify: Clinical Pharmacology Review Summary of Pediatric Studies
• Abilify: Labeling
• Atypical Antipsychotics: Safety Review on 5 Atypical Antipsychotics (PDF - 210KB)
• Atypical Antipsychotics: Use Reviews, including Abilify (PDF - 183KB)
• Atypical Antipsychotics: Abbreviated Clinical Summary Table of Metabolic Aes (PDF - 100KB)
• Atypical Antipsychotics: Additional Reference Information
• Atypical Antipsychotics: Geodon (ziprasidone) Labeling (PDF - 419KB)
• Atypical Antipsychotics: Risperidal (risperidone) Labeling (PDF - 1.3MB)
• Atypical Antipsychotics: Seroquel (quetiapine) XR Labeling (PDF - 154KB)
• Atypical Antipsychotics: Seroquel (quetiapine) Labeling (PDF - 303KB)
• Atypical Antipsychotics: Zyprexa (olanzapine) Labeling (PDF - 291KB)
• Humira: Safety Review (PDF - 232KB)
• Humira: Use Review (PDF - 150KB)
• Humira: Malignancy in Children Review (PDF - 2.8MB)
• FDA: Cancer Warnings Required for TNF Blockers
  Humira: Public Health Advisory
• Humira: Additional Reference Information
• 0125057s114_Adalimumab (Humira)_Clinical_PREA (PDF - 8.9MB)
  Humira: Clinical Review Summary of Pediatric Studies
• 0125057s114_Adalimumab (Humira)_Clinpharm_PREA (PDF - 1.4MB)
  Humira: Clinical Pharmacology Review of Pediatric Studies
• 0125057s114_Adalimumab (Humira)_Statistical_PREA (PDF - 2.8MB)
  Humira: Statistical Review of Pediatric Studies
• Humira: Labeling (PDF - 537KB)
• Orencia: Safety Review (PDF - 178KB)
• Orencia: Use Review (PDF - 145KB)
• 020883se8-014_Argatroban_Clinical_PREA.pdf (PDF - 168KB)
  Orencia: Clinical Review Summary of Pediatric Studies
• 0125118s045_Abatacept_Clinpharm_PREA.pdf (PDF - 4.1MB)
  Orencia: Clinical Pharmacology Review of Pediatric Studies
• 012510125118s045_Abatacept_Statistical_PREA.pdf (PDF - 23.4MB)
  Orencia: Statistical Review of Pediatric Studies
• Orencia: Labeling (PDF - 192KB)
• Argatroban: Safety Review (PDF - 128KB)
• Argatroban: Use Review (PDF - 106KB)
• 020883se8-014_Argatroban_Clinical_PREA.pdf (PDF - 168KB)
  Argratroban: Clinical Review of Pediatric Studies
• 020883se8-014_Argatroban_Clinpharm_PREA.pdf (PDF - 450KB)
  Argratroban: Clinical Pharmacology Review of Pediatric Studies
• Argatroban: Labeling (PDF - 339KB)
• Evicel: Safety Review (PDF - 59KB)
• Evicel: Use Review (PDF - 370KB)
• Clinical Efficacy Supplement Final Review Memo - Evicel (PDF - 319KB)
  Evicel: Clinical Review Summary of Pediatric Studies
• Evicel: Statistical Review of Pediatric Studies (PDF - 168KB)
• Evicel: Package Insert (PDF - 6.6MB)
• Artiss: Safety Review (PDF - 75KB)
• Artiss: Use Review (PDF - 276KB)
• Artiss: Statistical Review Summary of Pediatric Studies (PDF - 61KB)
• Artiss: Pharmacology-Toxicology Review of Pediatric Studies (PDF - 976KB)
• Artiss: Package Insert (PDF - 234KB)
• Voluven: Safety Review (PDF - 151KB)
• Voluven: Use Review (PDF - 232KB)
• Voluven: Review of Pediatric Studies (PDF - 47KB)
• Voluven: Clinical Pharmacology / Review Summary or Pediatric Studies (PDF - 153KB)
• Voluven: Package Insert (PDF - 420KB)
• Kaletra: Safety Review (PDF - 1MB)
• Kaletra: Use Review (PDF - 153KB)
• 021251_Lopinavir-Ritonavir_Clinical_BPCA.pdf (PDF - 3.2MB)
  Kaletra: Clinical Review Summary of Pediatric Studies
• 021226-21251_Lopinavir-Ritonavir_Clinpharm_BPCAini.pdf (PDF - 904KB)
  Kaletra: Clinical Pharmacology Review of Pediatric Studies
• Kaletra: Labeling (PDF - 1.4MB)
• Reyataz: Safety Review (PDF - 160KB)
• Reyataz: Use Review (PDF - 57KB)
• 021567s015_Atazanavir_Clinical_PREA.pdf (PDF - 3.6MB)
  Reyataz: Clinical Review Summary of Pediatric Studies
• 021567a015_Atazanavir_Clinpharm_PREA.pdf (PDF - 913KB)
  Reyataz: Clinical Pharmacology Review of Pediatric Studies
• Reyataz: Labeling (PDF - 426KB)
• Ventolin: Safety Review (PDF - 143KB)
• Ventolin: Use Review (PDF - 58KB)
• 020983s013_Albuterol_Clinical_BPCA.pdf (PDF - 1.3MB)
  Ventolin: Clinical Review Summary of Pediatric Studies
• 020983s013_Albuterol_Clinpharm_BPCA (PDF - 133KB)
  Ventolin: Clinical Pharmacology Review of Pediatric Studies
• 020983s013_Albuterol_Statistical_BPCA (PDF - 310KB)
  Ventolin: Statistical Review of Pediatric Studies
• Ventolin: Labeling (PDF - 350KB)
• Cancidas: Safety Review (PDF - 479KB)
• Cancidas: Use Review (PDF - 113KB)
• 021227_Caspofungin_Clinical_BPCA.pdf (PDF - 3.4MB)
  Cancidas: Clinical Review Summary of Pediatric Studies
• 021227_Caspofungin_Clinpharm_BPCA.pdf (PDF - 465KB)
  Cancidas: Clinical Pharmacology Review of Pediatric Studies
• 021227_Caspofungin_Statistical_BPCA.pdf (PDF - 352KB)
  Cancidas: Statistical Review of Pediatric Studies
• Cancidas: Labeling (PDF - 157KB)
• Aptivus: Safety Review (PDF - 199KB)
• Aptivus: Use Review (PDF - 188KB)
• 021814_Tipranavir_Clinical_BPCA.pdf (PDF - 1.5MB)
  Aptivus: Clinical Review Summary of Pediatric Studies
• 021814_Tipranavir_Clinpharm_BPCA.pdf (PDF - 1.7MB)
  Aptivus: Clinical Pharmacology Review of Pediatric Studies
• 021814_Tipranavir_Statistical_BPCA.pdf (PDF - 589KB)
  Aptivus: Statistical Review of Pediatric Studies
• Aptivus: Labeling (PDF - 369KB)
• Zetia/Vytorin: Safety Review (PDF - 127KB)
• Zetia/Vytorin: Use Review (PDF - 400KB)
• 021445_Ezetimibe_Clinical_BPCA_rev2_cd_SPONSOR_REVISED_7-16-08.pdf (PDF - 1.6MB)
  Zetia: Clinical Review Summary of Pediatric Studies
• 021687s023_Ezetimbe(Vytorin)_Clinical_PREA.pdf (PDF - 2.3MB)
  Vytorin: Clinical Review Summary of Pediatric Studies
• 021687s023_Ezetimbe(Vytorin)_Clinpharm_PREA.pdf (PDF - 179KB)
  Zetia/Vytorin: Clinical Pharmacology Review of Pediatric Studies
• 021687s023_021445s020_Ezetimbe(Vytorin)_Statistical_PREA.pdf (PDF - 330KB)
  Zetia/Vytorin: Statistical Review of Pediatric Studies
• Zetia: Labeling (PDF - 146KB)
• Vytorin: Labeling (PDF - 168KB)

Open Public Hearing Documents

• Open Public Hearing Witness List from the December 8, 2009 Meeting of the Pediatric Advisory Committee