Recently Updated Advisory Committee Materials

Recently Updated Advisory Committee Materials
Posted on December 03, 2010
Pediatric Advisory Committee

Meeting Roster for the December 6, 2010 Meeting of the Pediatric Advisory Committee (PDF - 244KB)

Xyzal: Safety Review (PDF - 807KB)

Neulasta: Medication Error Review (2010) (PDF - 1078KB)

Lamictal XR: Safety Review (PDF - 730KB)

Ulesfia: Use Review (PDF - 131KB)

Ulesfia: Labeling (PDF - 111KB)

Lamictal: Case Report: Lamotrigine Neonatal Exposure in Breast Milk

Acanya: Safety Review (PDF - 207KB)

PegIntron: Safety Review (PDF - 1635KB)

Acanya: Use Review (PDF - 130KB)

Acanya: Labeling (PDF - 385KB)

Ulesfia: Safety Review (PDF - 266KB)

Epiduo Gel: Use Review (PDF - 148KB)

Epiduo Gel: Labeling (PDF - 140KB)

Gardasil: Clinical and Use Review (2010) (PDF - 407KB)

Xyzal: Use Review (PDF - 136KB)

Flovent HFA: Safety Review (PDF - 1118KB)

Flovent HFA: Use Review (PDF - 55KB)

Neulasta: Use Review (PDF - 280KB)

Prezista: Labeling (PDF - 1292KB)

PegIntron: Use Review (PDF - 540KB)

PegIntron: Labeling (PDF - 807KB)

Axert: Safety Review (PDF - 693KB)

Axert: Use Review (PDF - 155KB)

Lamictal and Lamictal XR: Use Review (PDF - 210KB)

Lamictal: Labeling History Table (PDF - 161KB)

Lamictal XR Clinical Review (2010) (PDF - 560KB)

Lamictal XR Statistical Review Memo (PDF - 72KB)

Lamictal: Labeling (PDF - 395KB)

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 Tablets: Labeling (PDF - 453KB)

PegIntron: Memo, Alpha interferons and liver transplant rejection (PDF - 2931KB)

Ulesfia: Brief Summary of Pediatric AERS Cases, September. 2010 (PDF - 43KB)

Epiduo Gel: Safety Review (PDF - 386KB)

Gardasil: Labeling (PDF - 363KB)

Gardasil: JAMA Article: Postlicensure Safety Surveillance, for Quadrivalent, Human
Papillomavirus Recomonbinant, Vaccine

Xyzal: Labeling (PDF - 221KB)

Flovent HFA: Labeling (PDF - 651KB)

Neulasta: Safety Review (PDF - 2317KB)

Neulasta: Labeling (PDF - 384KB)

Prezista: Safety Review (PDF - 920KB)

Prezista: Use Review (PDF - 161KB)

Axert: Labeling (PDF - 300KB)

Lamictal: Review-PMHS Maternal Health Team (PDF - 204KB)

Lamictal XR Clinical Review Summary of Pediatric Studies memo (PDF - 19KB)

Lamictal XR: Labeling (PDF - 371KB)

Depakote ER: Labeling (PDF - 240KB)

Briefing Information for the December 7, 2010 Meeting of the Pediatric Advisory Committee

full-contents (please download pdf files):
Recently Updated Advisory Committee Materials