February 7, 2001

Briefing Information

NDA 20-998/S009 Celebrex (celecoxib)



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.

Briefing Information

Food and Drug Administration Briefing Information

Qualification   doc   pdf

Medical Officer Review   doc   pdf

Statistical Review   doc   pdf

Medical Officer's Gastroenterology Review   doc   pdf

Clinical Pharmacology/Biopharmaceutics Review   pdf

Comparative Safety of Celecoxib, Diclofenax and Ibuprofen   pdf

FDAs Division of Drug Risk Evaluation I (Office of Post-Marketing Drug Risk Assessment)

Qualification   doc   pdf

OPDRA Postmarketing Safety Review - Gastrointestinal   doc   pdf

OPDRA Postmarketing Safety Review - Renal   doc   pdf

OPDRA Postmarketing Safety Review - Thrombotic Vascular Events   doc   pdf