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).

• Memo From Dr. Dianne Murphy, Director of the Office of Pediatric Therapeutics, to the Committee (PDF - 22KB)
• Actonel: Safety Review (PDF - 85KB)
• Actonel: Use Review (PDF - 65KB)
• Actonel: Medical Review (PDF - 437KB)
• Actonel: ClinPharm Review (PDF - 636KB)
• Actonel: Statistical Review (PDF - 255KB)
• Actonel Label
• Astepro: Safety Review (PDF - 123KB)
• Astepro: Use Review (PDF - 51KB)
• Astepro: Medical Review (July 2009) (PDF - 663KB)
• Astepro: Medical Review (March 2009) (PDF - 3.3MB)
• Astepro: ClinPharm Review (PDF - 540KB)
• Astepro: Statistical Review (PDF - 985KB)
• Astepro: Statistical Review Addendum (PDF - 204KB)
• Astepro Label
• Bepreve: Safety Review (PDF - 79KB)
• Bepreve: Use Review (PDF - 54KB)
• Bepreve: Medical Review (PDF - 2.2MB)
• Bepreve: ClinPharm Review (PDF - 693KB)
• Bepreve: Statistical Review (PDF - 696KB)
• Bepreve Label
• Besivance: Safety Review (PDF - 83KB)
• Besivance: Use Review (PDF - 49KB)
• Besivance: Medical Review (PDF - 2.1MB)
• Besivance: ClinPharm Review (PDF - 684KB)
• Besivance: Statistical Review (PDF - 1.5MB)
• Besivance Label
• Cetraxal: Safety Review (PDF - 29KB)
• Cetraxal: Use Review (PDF - 46KB)
• Cetraxal: Medical Review (PDF - 282KB)
• Cetraxal: ClinPharm Review (PDF - 245KB)
• Cetraxal: Statistical Review (PDF - 511KB)
• Cetraxal Label
• Crestor: Safety Review (PDF - 91KB)
• Crestor: Use Review (PDF - 70KB)
• Crestor: Medication Error Review (PDF - 38KB)
• Crestor: Medical Review (PDF - 2.4MB)
• Crestor: ClinPharm Review (PDF - 602KB)
• Crestor: Statistical Review (PDF - 482KB)
• Crestor Label
• Hiberix: Safety and Utilization Review (PDF - 38KB)
• Hiberix: 2009 Press Release [ARCHIVED]
• MMWR Article: Progress Toward Eliminating Haemophilus influenzae Type b Disease Among Infants
• Hiberix: Clinical Review (PDF - 934KB)
• Hiberix: Statistical Review (PDF - 643KB)
• Hiberix Label, December 2010 (PDF - 120KB)
• Intuniv: Safety Review (PDF - 173KB)
• Intuniv: Use Review (PDF - 66KB)
• Intuniv: Medical Review (PDF - 4.7MB)
• Intuniv: Memorandum July 2009 (PDF - 118KB)
• Intuniv: Memorandum September 2009 (PDF - 35KB)
• Intuniv: ClinPharm Review (PDF - 3.9MB)
• Intuniv: Statistical Review (PDF - 173KB)
• Intuniv Label
• Lexapro: Safety Review (PDF - 186KB)
• Lexapro: Use Review (PDF - 53KB)
• Lexapro Article: Suicidality in Pediatric Patients Treated with Antidepressant Drugs
• Lexapro Article: Changes in US antidepressant and antipsychotic prescription patterns during a period of FDA actions (Abstract)
• Lexapro Article: Suicide and Antidepressants. Beware extrapolation from ecological data (Reference)
• Lexapro: Medical Review (PDF - 1.4MB)
• Lexapro: ClinPharm Review (PDF - 655KB)
• Lexapro: Statistical Review (PDF - 772KB)
• Lexapro: Labeling (February 2011)
• Patanase: Safety Review (PDF - 138KB)
• Patanase: Use Review (PDF - 66KB)
• Patanase: Medical Review (PDF - 3.4MB)
• Patanase: ClinPharm Review (PDF - 2.4MB)
• Patanase: Statistical Review (PDF - 3.2MB)
• Patanase Labeling
• Valcyte: Safety Review (PDF - 166KB)
• Valcyte: Use Review (PDF - 65KB)
• Valcyte: Medical Review August 2009 (PDF - 1MB)
• Valcyte: ClinPharm Review April 2008 (PDF - 1.5MB)
• Valcyte: Statistical Review (PDF - 19KB)
• Valcyte Label
• Welchol: Safety Review (PDF - 90KB)
• Welchol: Use Review (PDF - 70KB)
• Welchol: Medical Review (PDF - 8MB)
• Welchol: Statistical Review (PDF - 4MB)
• Welchol Labeling
• Topical Calcineurin Inhibitors: Literature Review (PDF - 351KB)
• Topical Calcineurin Inhibitors: Literature Review Addendum (PDF - 97KB)
• Topical Calcineurin Inhibitors: Safety Review Follow-Up (PDF - 139KB)
• Protopic (tacrolimus) Label
• Elidel (pimecrolimus) Label