Acipheix Sprinkle (rabeprazole Sodium) 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

• ACIPHEX SPRINKLE Labeling, 12/19/2014
• ACIPHEX SPRINKLE Safety and Drug Utilization Review
• Presentation: Pediatric Focused Safety Review Aciphex Sprinkle (rabeprazole)
• ACIPHEX SPRINKLE Clinical Review
• ACIPHEX SPRINKLE Clinical Pharmacology Review
• ACIPHEX SPRINKLE Statistical Review

ResourcesForYou

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