Seroquel (quetiapine fumarate) and Seroquel XR (quetiapine fumarate extended-release) Briefing Materials
For the April 12, 2016 meeting of the FDA's Pediatric Advisory Committee
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Briefing Materials
- SEROQUEL (quetiapine fumarate) Labeling, 10/29/2013
- SEROQUEL XR Labeling, 10/29/2013
- SEROQUEL (quetiapine fumarate) and SEROQUEL XR Safety and Drug Utilization Review
- SEROQUEL (quetiapine fumarate) and SEROQUEL XR Jan. 30-31, 2012 PAC Safety and Drug Utilization Review
- Presentation: Pediatric Focused Safety Review: Seroquel (quetiapine fumarate) Seroquel XR (quetiapine fumarate, extended release)
- SEROQUEL (quetiapine fumarate) Transplacental Safety Memo
- SEROQUEL XR Clinical Review Memo
- SEROQUEL XR Clinical Review
- SEROQUEL XR Clinical Pharmacology Review
- SEROQUEL XR Clinical Pharmacology Review Amendment
- SEROQUEL XR Statistical Review
Resources For You
- Products and Briefing Materials for the April 12, 2016 Meeting of the Pediatric Advisory Committee
- 2016 Meeting Materials, Pediatric Advisory Committee