Advisory Committees
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Briefing Materials for the Sept. 22-23, 2011 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 Materials: September 22, 2011
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).
Abilify Safety Review: 2011 (PDF - 575KB)Abilify Use Review 2011 (PDF - 119KB)- Abilify Clinical Review 2009 (PDF - 1.2MB)
- Abilify Clinical Review Addendum 2009 (PDF - 65KB)
- Abilify Statistical Review 2009 (PDF - 338KB)
- Abilify Safety Review 2009 (PDF - 556KB)
- Abilify Use Review 2009 (PDF - 183KB)
Abilify Labeling (3/2/2011) Abstract: Atypical Antipsychotic Drug Use in the U.S. Outpatient Pediatric Population (PDF - 59KB)Abilify Expert Opinion Drug Metabolism and Toxicology Article Afluria Safety and Use Review (PDF - 112KB)- Afluria Package Insert (PDF - 265KB)
- Afluria Clinical Review (PDF - 803KB)
- Afluria Statistical Review (PDF - 245KB)
- Afluria 2007 Press Release [ARCHIVED]
- Afluria 2009 Press Release
- Afluria Related FDA Q and As
- Afluria: CBER 2007 Guidance on Accelerated Approval
- Afluria: FDA MedWatch Posting
Afluria: CDC Vaccine Information Statement Article: Adverse Events in Children Following 2010 Southern Hemisphere Influenza Vaccination - Afluria Package Insert (7/2011) (PDF - 1.5MB)
Fluarix Safety and Use Review (PDF - 180KB)Fluarix ACIP recommendations (07/24/2009) Fluarix ACIP recommendations (08/13/2010) - Fluarix Package Insert (4/2011) (PDF - 259KB)
- Fluarix Clinical Review
- Fluarix Statistical Review
- Fluarix Dear Health Care Provider Letter
Influenza Vaccines and Neurological Complications. (National Research Council)
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Briefing Materials: September 23, 2011
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).
Melody TPV Executive Summary (including Safety Review) (PDF - 862KB)Melody TPV Appendix (PDF - 70KB)Melody TPV Labeling (PDF - 454KB)Melody TPV Heart Article Melody TPV Journal of the American College of Cardiology Article Melody TPV Circulation Article - Melody TPV background materials from the July 2009 meeting
- Navstel Safety Review (PDF - 36KB)
- Navstel Use Review (PDF - 67KB)
- Navstel Clinical Review (PDF - 4.2MB)
- Navstel Clinical Pharmacology Review (PDF - 49KB)
Navstel Labeling (7/2008) Akten Safety Review (PDF - 36KB)Akten Use Review (PDF - 67KB)- Akten Clinical Review (PDF - 120KB)
- Akten Clinical Pharmacology Review (PDF - 56KB)
- Akten Statistical Review (PDF - 292KB)
Akten Labeling (10/07/2008) - Triesence Safety Review (PDF - 36KB)
- Triensence Use Review (PDF - 67KB)
- Triesence Clinical Review (PDF - 2.1MB)
- Triesence Clinical Pharmacology Review (PDF - 802KB)
- Triesence Statistical Review (PDF - 402KB)
Triesence Labeling (11/2007) Famvir Safety Review (PDF - 331KB)Famvir Use Review (PDF - 70KB)- Famvir Clinical Review (PDF - 779KB)
- Famvir Clinical Pharmacology Review (PDF - 354KB)
- Famvir Labeling (1/2011)
Videx EC Safety Review (PDF - 129KB)Videx EC Use Review (PDF - 74KB)- Videx EC Clinical Review (PDF - 483KB)
- Videx EC Clinical Pharmacology Review (PDF - 830KB)
Videx EC Labeling (2/2011) 
Ziagen Safety Review (PDF - 694KB)Ziagen Use Review (PDF - 61KB)- Ziagen Clinical Review (PDF - 588KB)
- Ziagen Clinical Pharmacology Review (PDF - 248KB)
Ziagen Labeling (9/2010)
Zomig Nasal Spray Safety Review (PDF - 213KB)Zomig Nasal Spray Use Review (PDF - 64KB)- Zomig Nasal Spray Clinical Review (PDF - 1.5MB)
- Zomig Nasal Spray Clinical Pharmacology Review (PDF - 703KB)
- Zomig Nasal Spray Statistical Review (PDF - 244KB)
Zomig Nasal Spray Labeling (10/2008)
Topamax Safety Review (PDF - 1.2MB)Topamax Use Review (PDF - 109KB)- Topamax Clinical Review (PDF - 3MB)
- Topamax Clinical Pharmacology Review (PDF - 986KB)
Topamax Clinical Pharmacology Review (June 2010) (PDF - 953KB)Topamax Safety Review: Use During Pregnancy (PDF - 1.4MB)Topamax PMHS-Maternal Health Team Memo (PDF - 102KB)Topamax Labeling (7/2011) Topamax FDA News Briefing (March 7, 2011, 4th paragraph)
Topamax Clinical Review (July 2011) (PDF - 2.7MB)Retrovir Safety Review (PDF - 928KB)Retrovir Use Review (PDF - 141KB)- Retrovir Clinical Review- Medical Officer Review of Supplemental Labeling Revisions (PDF - 767KB)
- Retrovir Clinical Pharmacology Review (PDF - 686KB)
Retrovir Pediatric Medication Errors (PDF - 477KB)Retrovir Labeling (1/2011)
Levaquin Safety Review (PDF - 134KB)Levaquin Use Review (PDF - 78KB)- Levaquin Clinical Review (PDF - 239KB)
- Levaquin Clinical Pharmacology Review (PDF - 828KB)
- Levaquin Statistical Review (PDF - 39KB)
Levaquin Pediatric Advisory Committee Nov 2008 Slides Levaquin Labeling (6/09/2011) Kaletra Safety Review (PDF - 476KB)- Kaletra: Slides from Dec. 2009 Pediatric Advisory Committee meeting (PDF - 141KB)
- Kaletra Labeling (2/2011)
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