Asacol & Asacol HD, and Delzicol (mesalamine) Briefing Materials
For the September 14, 2016 meeting of the FDA's Pediatric Advisory Committee
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Briefing Materials
- Asacol and Asacol HD Safety and Drug Utilization Review
- Asacol HD Clinical Review
- Asacol HD Labeling, 5/2016
- Asacol Labeling 5/2015 (no longer marketed)
- Asacol HD Clinical Pharmacology Review, 2012
- Asacol HD Clinical Pharmacology Review, 2013
- Asacol HD Statistical Review
- Delzicol Labeling, 9/2015
- Delzicol Safety and Drug Utilization Review
- Delzicol Clinical Review 2/2014
- Delzicol Clinical Review 8/2015
- Delzicol Clinical Review Addendum 4/2014
- Delzicol Clinical Pharmacology Review, 2/2014
- Delzicol Clinical Pharmacology Review,8/2015
- Delzicol Statistical Review
- Presentation: Pediatric Focused Safety Review for Asacol and Delzicol