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 Letter (June 21, 2010) (PDF - 15KB)
• Federal Register Notice (PDF - 49KB)
• Arimidex: Safety Review (PDF - 130KB)
• Arimidex: Use Review (PDF - 65KB)
• Arimidex: Clinical Review Summary of Pediatric Studies (PDF - 1.6MB)
• Arimidex: Clinical Pharmacology Review of Pediatric Studies (PDF - 5MB)
• Arimidex: Clinical Statistical Review and Evaluation (PDF - 1008KB)
• Arimidex: Labeling (February 2010) (PDF - 613KB)
• Casodex: Safety Review (PDF - 116KB)
• Casodex: Use Review (PDF - 66KB)
• Casodex: Clinical Review of Pediatric Studies (PDF - 1.4MB)
• Casodex: Clinical Pharmacology Review of Pediatric Studies (PDF - 511KB)
• Casodex: Statistical Review and Evaluation (PDF - 167KB)
• Casodex: Labeling (November 2009) (PDF - 326KB)
• OraVerse: Safety Review (PDF - 37KB)
• OraVerse: Use Review (Sponsor) (PDF - 13KB)
• OraVerse: Clinical Review Summary of Pediatric Studies (PDF - 3.7MB)
• OraVerse: Clinical Pharmacology Review of Pediatric Studies (PDF - 1.4MB)
• OraVerse: Statistical Review of Pediatric Studies (PDF - 762KB)
• OraVerse: Labeling (May 2008) (PDF - 164KB)
• Desmopressin: Safety Review (PDF - 82KB)
• Desmopressin: Use Review (PDF - 57KB)
• Desmopressin: 2005 Clinical Review Summary of Pediatric Studies (PDF - 392KB)
• Desmopressin: Resubmission of 2008 Medical Office Review (PDF - 161KB)
• Desmopressin: Clinical Pharmacology Review of Studies (PDF - 797KB)
• Desmporessin: Labeling (April 2008) (PDF - 404KB)
• Apridra: Safety Review (PDF - 86KB)
• Apridra: Use Review (PDF - 70KB)
• Apridra: Clinical Review Summary of Pediatric Studies (PDF - 745KB)
• Apridra: Clinical Pharmacology Review of Pediatric Studies (PDF - 714KB)
• Apridra: Statistical Review of Pediatric Studies (PDF - 391KB)
• Apridra: Labeling (March 2009) (PDF - 535KB)
• Novolog: Safety Review (PDF - 128KB)
• Novolog: Use Review (PDF - 68KB)
• Novolog: Clinical Review of Pediatric Studies (PDF - 1.1MB)
• Novolog: Clinical Pharmacology Review of Pediatric Studies (PDF - 85KB)
• Novolog: Statistical Review of Pediatric Studies (PDF - 159KB)
• Novolog: Labeling (March 2010) (PDF - 1MB)
• Proton Pump Inhibitors: Safety Review (PDF - 234KB)
• Proton Pump Inhibitors: Use Review (PDF - 315KB)
• Possible Increased Risk of Bone Fractures With Certain Antacid Drugs
  FDA Consumer Alert
• Proton Pump Inhibitor: Utilization Patterns in Infants (PDF - 150KB)
  Article: Journal of Pediatric Gastroenterology and Nutrition
• Prevacid: Clinical Review Summary of Pediatric Study (PDF - 888KB)
• Prevacid: Clinical Pharmacology Review of Pediatric Study (PDF - 1.5MB)
• Prevacid: Statistical Review of Pediatric Study (PDF - 46KB)
• Prevacid: Labeling (May 2010) (PDF - 339KB)
• Nexium: Clinical Review Summary of Pediatric Studies (PDF - 1.1MB)
• Nexium: Clinical Pharmacology Review of Pediatric Studies (PDF - 1.9MB)
• Nexium: Statistical Review and Evaluation (PDF - 294KB)
• Nexium: Labeling (March 2010) (PDF - 363KB)
• Aciphex: Clinical Review Summary of Pediatric Studies (PDF - 534KB)
• Aciphex: Clinical Pharmacology Review of Pediatric Studies (PDF - 687KB)
• Aciphex: Labeling (February 2009) (PDF - 401KB)
• Prilosec: Clinical Review Summary of Pediatric Studies (PDF - 295KB)
• Prilosec: Clinical Pharmacology Review of Pediatric Studies (PDF - 868KB)
• Prilosec: Labeling (March 2010) (PDF - 245KB)
• Kogenate: Safety Review (PDF - 100KB)
• Kogenate: Use Review (PDF - 123KB)
• Kogenate: CBER 2008 Medical Review (PDF - 332KB)
• Kogenate: CDRH 2008 Clinical Review Memo (PDF - 38KB)
• Kogenate: CDRH 2008 Supplemental Review Memo (PDF - 140KB)
• Kogenate: Labeling (March 2010) (PDF - 403KB)
• Suprane: Safety Review (PDF - 116KB)
• Suprane: Use Review (PDF - 57KB)
• Suprane: 2008 Safety Review (PDF - 179KB)
• Suprane: 2008 Pediatric Advisory Committee Meeting Minutes (PDF - 110KB)
• Suprane: Labeling (February 2010) (PDF - 207KB)
• Suprane: 2009 OSE Review (PDF - 64KB)
• Zemuron: Safety Review (PDF - 228KB)
• Zemuron: Use Review (PDF - 38KB)
• Zemuron: Clinical Review Summary of Pediatric Studies (PDF - 1.3MB)
• Zemuron: Clinical Pharmacology Review of Pediatric Studies (PDF - 877KB)
• Zemuron: Labeling (March 2010) (PDF - 300KB)