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Celebrex, Vioxx GI Safety Differences May Be Indistinguishable - FDA Cmte.

Executive Summary

Gastrointestinal safety outcome differences between Pharmacia/Pfizer's Celebrex and Merck's Vioxx may be a factor of statistical "technicalities," FDA Arthritis Advisory Committee voting consultant David Wofsy, MD, University of California-San Francisco, suggested.

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Novartis Prexige advisory committee?: Novartis Prexige gastrointestinal and cardiovascular safety study on COX-2 inhibitor could be subject of FDA advisory committee meeting next year, Global Pharma Development Head Joerg Reinhardt, PhD, tells analysts July 21. Final results from 18,000-patient TARGET study will be available in early 2004 (1"The Pink Sheet" Nov. 21, 2001, p. 32). FDA's arthritis committee reviewed similar outcomes studies for Pfizer's Celebrex and Merck's Vioxx in 2001 (2"The Pink Sheet" Feb. 12, 2001, p. 6). Novartis has not yet heard whether the Prexige (lumiracoxib) NDA will be the subject of committee review. Prexige's user fee deadline is in late September...

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