Xolair (omalizumab) Briefing Materials
For the September 14, 2016 meeting of the FDA's Pediatric Advisory Committee
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Briefing Materials
- Xolair labeling, 7/2016
- Xolair Safety and Utilization Review
- Presentation: Pediatric Focused Safety Review for Xolair
- Xolair Clinical Review
- Xolair Clinical Pharmacology Review
- Xolair Statistical Review