Advisory Committees
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Briefing Materials for the January 30-31 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
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).
Atacand Safety Review (PDF - 2MB)Atacand Use Review (PDF - 72KB)- Atacand Labeling, April 2011
Atacand Medical Review Atacand Pharmacology Review - Atacand Statistical Review (PDF - 435KB)
Benicar Safety Review (PDF - 1.7MB)Benicar Use Review (PDF - 71KB)- Benicar Labeling, May 2011
- Benicar Medical Review (PDF - 2.4MB)
- Benicar Pharmacology Review (PDF - 964KB)
- Benicar Statistical Review (PDF - 527KB)
Cervarix Safety and Utilization Review (PDF - 162KB)- Cervarix Labeling, 2011 (PDF - 289KB)
- Cervarix Clinical Review (PDF - 16.9MB)
- Cervarix Statistical Review
Cervarix Press Release, Oct. 2009 Creon (pancrelipase) Safety Review (PDF - 236KB)Creon (pancrelipase) Use Review (PDF - 95KB)- Creon Labeling, July 2011
- Creon Medical Review (PDF - 702KB)
- Creon ClinPharm Review (PDF - 58KB)
- Creon Statistical Review (PDF - 84KB)
Daytrana Safety Review (PDF - 398KB)Daytrana Use Review (PDF - 73KB)- Daytrana Labeling, June 2010
- Daytrana Clinical Review (PDF - 2MB)
- Daytrana Clinical Review Memo (PDF - 36KB)
- Daytrana Pharmacology Review (PDF - 568KB)
- Daytrana Statistical Review (PDF - 162KB)
Flomax Safety Review (PDF - 365KB)Flomax Safety Addendum (PDF - 92KB)Flomax Use Review (PDF - 198KB)Flomax Medication Errors Review (PDF - 125KB)- Flomax Labeling, July 2011
- Flomax Medical Review (PDF - 3.2MB)
- Flomax Pharmacology Review (PDF - 1.1MB)
- Flomax Statistical Review (PDF - 253KB)
Focalin XR Safety Review (PDF - 374KB)Focalin XR Use Review (PDF - 240KB)Focalin and Focalin XR Angioedema and Anaphylaxis Review (PDF - 102KB)- Focalin XR Clinical Review (PDF - 333KB)
Focalin XR labeling, December 2010 ADHD Drugs – New England Journal of Medicine Article - Focalin XR Pharmacology Review (PDF - 830KB)
- Focalin XR Statistical Review (PDF - 151KB)
Focalin XR Statistical Review Addendum (PDF - 34KB)Mirena (levonorgestrael – releasing intrauterine system) Safety Review (PDF - 2.6MB)Mirena (levonorgestrael – releasing intrauterine system) Use Review (PDF - 102KB)- Mirena Labeling, October 2009
- Mirena ClinPharm Review (PDF - 359KB)
- Mirena Clinical Review (PDF - 1MB)
- Mirena Statistical Review (PDF - 70KB)
Pancreaze Labeling, September 2011 
Pancreaze (pancrelipase) Safety Review (PDF - 8.4MB)Pancreaze (pancrelipase) Use Review (PDF - 94KB)- Pancreaze Medical Review (PDF - 1.5MB)
- Pancreaze ClinPharm Review (PDF - 546KB)
- Pancreaze Statistical Review (PDF - 326KB)
Plan B One-Step Use Review (PDF - 155KB)Plan B One-Step Safety Review (PDF - 119KB)- Plan B One-Step Labeling (July 2009)
Plan B One-Step Medical Review Plan B One-Step Medical Review – continued Plan B One-Step ClinPharm Review Plan B One-Step Statistical Review Prevnar 13 Safety and Use Review (PDF - 150KB)- Prevnar 13 Labeling, January 2012 (PDF - 734KB)
- Prevnar 13 Clinical Review (PDF - 1.1MB)
- Prevnar 13 Statistical Review (PDF - 1.1MB)
- Prevnar 13 Press Release, February 2010 [ARCHIVED]
Seroquel Safety Review (PDF - 472KB)Seroquel Use Review (PDF - 167KB)Seroquel Labeling, November 2011 Seroquel XR Labeling, November 2011 - Seroquel Medical Review (PDF - 2.5MB)
- Seroquel Medical Review Addendum (PDF - 700KB)
- Seroquel ClinPharm Review (PDF - 2MB)
- Seroquel Statistical Review (PDF - 776KB)
Xerese (acyclovir; hydrocortisone) Safety Review.pdf (PDF - 26KB)Xerese (acyclovir; hydrocortisone) Use Review.pdf (PDF - 73KB)- Xerese Labeling, May 2010
- Xerese Medical and Statistical Review (PDF - 1.2MB)
- Xerese ClinPharm Review (PDF - 120KB)
Xolair Safety Review (PDF - 2MB)Xolair Use Review (PDF - 173KB)Xolair Labeling, July 2010 - Xolair Medical Review (PDF - 1.3MB)
- Xolair Pharmacology Review (PDF - 845KB)
- Xolair Statistical Review (PDF - 703KB)
Zenpep (pancrelipase) Safety Review (PDF - 231KB)Zenpep (pancrelipase) Use Review (PDF - 91KB)Zenpep Labeling, July 2011 Zenpep Medical Review Zenpep ClinPharm Review Zenpep Statistical Review
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