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).

• Afinitor Safety Review (PDF - 203KB)
• Afinitor Use Review (PDF - 115KB)
• Afinitor Labeling (8/2012) (PDF - 656KB)
• Afinitor Clinical and Statistical Review (PDF - 3.3MB)
• Afinitor ClinPharm Review (PDF - 1.6MB)
• Afinitor Press Release (8/2012), FDA approves first drug formulated for children with rare brain tumor
• Aridol Safety Review (PDF - 244KB)
• Aridol Use Review (PDF - 57KB)
• Aridol Labeling (10/2010)
• Aridol Medical Review (PDF - 396KB)
• Aridol ClinPharm Review (PDF - 226KB)
• Aridol Statistical Review (PDF - 1.9MB)
• Augmentin XR Safety Review (PDF - 259KB)
• Augmentin XR Use Review (PDF - 315KB)
• Augmentin XR Labeling (8/2011)
• Augmentin XR Medical Review (PDF - 67KB)
• Augmentin XR ClinPharm Review (PDF - 264KB)
• Beyaz Safety Review (PDF - 416KB)
• Beyaz Use Review (PDF - 467KB)
• FDA Drug Safety Communication (4/2012)
• Beyaz Labeling (4/2012)
• Beyez Medical Review (PDF - 2.1MB)
• Beyez ClinPharm Review (PDF - 1.9MB)
• Beyez Statistical Review (PDF - 399KB)
• Beyaz Statistical Addendum (PDF - 22KB)
• Elana Surgical Kit (HUD) Executive Summary (PDF - 330KB)
• Elana Surgical Kit (HUD) Labeling (3/2011)
• ella Safety Review (PDF - 204KB)
• ella Use Review (PDF - 306KB)
• ella Lableing (4/2012)
• ella Clinical Review (PDF - 1.3MB)
• ella ClinPharm Review (PDF - 2.1MB)
• ella ClinPharm Addendum (PDF - 46KB)
• ella Statistical Review (PDF - 2.8MB)
• Kapvay Safety Review (PDF - 379KB)
• Kapvay Use Review (PDF - 255KB)
• Clonidine Adverse Event (3/2007) (PDF - 492KB)
• Review: Death with the concomitant use of clonidine or guanfacine and amphetamine/dextroamphetamine or dexmethylphenidate or dextroamphetamine or lisdexamfetamine or methylphenidate (PDF - 249KB)
• Kapvay Labeling (9/2010)
• Clonidine (Catapres) Labeling (5/2012)
• Kapvay Clinical Review (PDF - 1.1MB)
• Kapvay ClinPharm Review (PDF - 224KB)
• Kapvay Statistical Review (PDF - 531KB)
• Lastacaft Safety Review (PDF - 102KB)
• Lastacaft Use Review (PDF - 241KB)
• Lastacaft Labeling (9/2011) (PDF - 544KB)
• Lastacaft Medical Review (PDF - 597KB)
• Lastacaft ClinPharm Review (PDF - 741KB)
• Lastacaft Statistical Review (PDF - 1.3MB)
• Lo Loestrin Fe Safety Review (PDF - 146KB)
• Lo Loestrin Fe Use Review (PDF - 352KB)
• Lo Loestrin Fe Labeling (10/2010)
• Lo Loestrin Fe Clinical Review (PDF - 91KB)
• Lo Loestrin Fe ClinPharm Review (PDF - 28KB)
• Lo Loestrin Fe Statistical Review (PDF - 36KB)
• Melody Transcatheter Pulmonary Valve Therapy Executive Summary (PDF - 414KB)
• Melody Transcatheter Pulmonary Valve Labeling (1/2010)
• Ofirmev Safety Review (PDF - 620KB)
• Ofirmev Use Review (PDF - 91KB)
• Ofirmev Medical Error Review (PDF - 2.5MB)
• Ofirmev Labeling (11/2010)
• Ofirmev Medical Review (10/6/2009, Clinical Safety) (PDF - 2.3MB)
• Ofirmev Medical Review (10/17/2009, Clinical Efficacy) (PDF - 921KB)
• Ofirmev ClinPharm Review (PDF - 2.2MB)
• Vyvanse Safety Review (PDF - 850KB)
• Vyvanse Use Review (PDF - 291KB)
• Vyvanse Labeling (1/2012)
• Vyvanse Medical Review (PDF - 1.7MB)
• Vyvanse Satistical Review (PDF - 676KB)