ARTHRITIS ADVISORY COMMITTEE
February 7, 2001
Briefing Information
NDA 20-998/S009 Celebrex (celecoxib)
Searle
Disclaimer
The statements contained in this document are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
Food and Drug Administration Briefing Information
Medical Officer Review doc pdf
Medical Officer's Gastroenterology Review doc pdf
Clinical Pharmacology/Biopharmaceutics Review pdf
Comparative Safety of Celecoxib, Diclofenax and Ibuprofen pdf
FDA’s Division of Drug Risk Evaluation I (Office of Post-Marketing Drug Risk Assessment)
OPDRA Postmarketing Safety Review - Gastrointestinal doc pdf
OPDRA Postmarketing Safety Review - Renal doc pdf
OPDRA Postmarketing Safety Review - Thrombotic Vascular Events doc pdf