Symbyax (fluoxetine hydrochloride and olanzapine) Briefing Materials

For the April 12, 2016 meeting of the FDA's Pediatric Advisory Committee

Persons with disabilities having problems accessing any of the PDF files below may call 240-402-3838 for assistance.

Briefing Materials

• SYMBYAX Labeling, 8/2015
• SYMBYAX Safety and Utilization Review
• Presentation: Pediatric Focused Safety Review: Symbyax (olanzapine and fluoxetine hydrochloride)
• SYMBYAX Clinical Review
• SYMBYAX Clinical Pharmacology Review
• SYMBYAX Clinical Pharmacology Review Addendum
• SYMBYAX Statistical Review

ResourcesForYou

• Products and Briefing Materials for the April 12, 2016 Meeting of the Pediatric Advisory Committee
• 2016 Meeting Materials, Pediatric Advisory Committee