Advisory Committees
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Briefing Information for the December 7, 2010 Meeting of the Pediatric Advisory Committee
Persons with disabilities having problems accessing any of the PDF files below may call (301) 796-3634 for assistance.
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Briefing Information - 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).
Acanya: Safety Review (PDF - 207KB)Acanya: Use Review (PDF - 130KB)- Acanya: Clinical Review Summary of Pediatric Studies (PDF - 1.7MB)
- Acanya: Clinical Pharmacology Review of Pediatric Studies (PDF - 497KB)
- Acanya: Statistical Review of Pediatric Studies (PDF - 836KB)
Acanya: Labeling (PDF - 385KB)Ulesfia: Safety Review (PDF - 266KB)Ulesfia: Use Review (PDF - 131KB)Ulesfia: Brief Summary of Pediatric AERS Cases, September. 2010 (PDF - 43KB)- Ulesfia: Clinical Review of Pediatric Studies (PDF - 299KB)
- Ulesfia: Clinical Pharmacology Review of Pediatric Studies (PDF - 268KB)
- Ulesfia: Statistical Review of Pediatric Studies (PDF - 932KB)
Ulesfia: Labeling (PDF - 111KB)Epiduo Gel: Safety Review (PDF - 386KB)Epiduo Gel: Use Review (PDF - 148KB)- Epiduo Gel: Clinical Review Summary of Pediatric Studies (PDF - 2.6MB)
- Epiduo Gel: Clinical Pharmacology Review of Pediatric Studies (PDF - 1.3MB)
- Epiduo Gel: Statistical Review of Pediatric Studies (PDF - 1.5MB)
Epiduo Gel: Labeling (PDF - 140KB)Gardasil: Safety and Use Review (2010) (PDF - 407KB)- Gardasil: Clinical Review Summary of Pediatric Studies (2008) (PDF - 2.5MB)
- Gardasil: Statistical Review and Evaluation (2008)
Gardasil: Labeling (PDF - 363KB)- Gardasil: JAMA Article: Postlicensure Safety Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine
- Gardasil: MMWR: Quadrivalent Human Papillomavirus Recombinant Vaccine
Xyzal: Safety Review (PDF - 807KB)Xyzal: Use Review (PDF - 136KB)- Xyzal: Clinical Review Summary of Pediatric Studies (2007) (PDF - 1MB)
- Xyzal: Clinical Review Summary of Pediatric Studies (2009) (PDF - 97KB)
- Xyzal: Clinical Pharmacology Review of Pediatric Studies (2007) (PDF - 419KB)
- Xyzal: Clinical Pharmacology Review of Pediatric Studies (2009) (PDF - 668KB)
Xyzal: Labeling (PDF - 221KB)Flovent HFA: Safety Review (PDF - 1.1MB)Flovent HFA: Use Review (PDF - 55KB)- Flovent HFA: Clinical Review Summary of Pediatric Studies (PDF - 337KB)
- Flovent HFA: Clinical Pharmacology Review of Pediatric Studies (PDF - 860KB)
Flovent HFA: Labeling (PDF - 651KB)Neulasta: Safety Review (PDF - 2.3MB)Neulasta: Use Review (PDF - 280KB)Neulasta: Medication Error Review (2010) (PDF - 1.1MB)- Neulasta: Medical Review (2008) (PDF - 965KB)
- Neulasta: Clinical Pharmacology Review of Studies (PDF - 945KB)
Neulasta: Labeling (PDF - 384KB)Prezista: Safety Review (PDF - 920KB)Prezista: Use Review (PDF - 161KB)- Prezista: Clinical Review of Pediatric Studies (PDF - 1.5MB)
- Prezista: Clinical Pharmacology Review of Pediatric Studies (PDF - 949KB)
Prezista: Labeling (PDF - 1.3MB)PegIntron: Safety Review (PDF - 1.6MB)PegIntron: Memo, Alpha interferons and liver transplant rejection (PDF - 2.9MB)PegIntron: Use Review (PDF - 540KB)- PegIntron: Clinical Review of Pediatric Studies (PDF - 937KB)
- PegIntron: Clinical Pharmacology Review of Pediatric Studies (PDF - 525KB)
- PegIntron: Clinical Statistical Review and Evaluation (PDF - 1MB)
PegIntron: Labeling (PDF - 807KB)Axert: Safety Review (PDF - 693KB)Axert: Use Review (PDF - 155KB)- Axert: Clinical Review Summary of Pediatric Studies (PDF - 8.7MB)
- Axert: Clinical Pharmacology Review of Pediatric Studies (PDF - 1.2MB)
Axert: Labeling (PDF - 300KB)Lamictal XR: Safety Review (PDF - 730KB)- Lamictal and Lamictal XR: Use Review (PDF - 210KB)
Lamictal: Review-PMHS Maternal Health Team (PDF - 204KB)Lamictal: Labeling History Table (PDF - 161KB)Lamictal: Case Report: Lamotrigine Neonatal Exposure in Breast Milk Lamictal XR Clinical Review (2010) (PDF - 560KB)Lamictal XR Clinical Review Summary of Pediatric Studies memo (PDF - 19KB)- Lamictal XR: Clinical Review Summary of Pediatric Studies (2009) (PDF - 52KB)
- Lamictal XR: Clinical Pharmacology Review of Pediatric Studies (2007) (PDF - 2.5MB)
Lamictal XR Statistical Review Memo (PDF - 72KB)- Lamictal XR: Statistical Review (PDF - 472KB)
Lamictal XR: Labeling (PDF - 371KB)Lamictal: Clinical Review Summary and Pharmacology Review (2007) Lamictal: Labeling (PDF - 395KB)- Depakote ER: 2009 PAC Meeting Minutes (PDF - 242KB)
- Depakote ER: 2009 PAC Meeting Presentation Slides (PDF - 62KB)
Depakote ER: Clinical Review Summary of Pediatric Studies (October 2010) (PDF - 925KB)Depakote ER: NEJM: Cognitive Function at 3 Years of Age After Fetal Exposure to Antiepileptic Drugs Depakote ER: Labeling (PDF - 240KB)Depakote Tablets: Labeling (PDF - 453KB)
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