Precedex (dexmedetomidine hydrochloride) Briefing Materials
For the April 12, 2016 meeting of the FDA's Pediatric Advisory Committee
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Briefing Materials
- PRECEDEX Labeling, 7/2015
- PRECEDEX Safety and Drug Utilization Review
- Presentation: Pediatric Focused Safety Review Precedex (dexmedetomidine)
- PRECEDEX Clinical Review
- PRECEDEX Clinical Pharmacology Review
- PRECEDEX Statistical Review