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COX-2 GI Labeling Changes Will Have Minimal Impact, Pharmacia Predicts

Executive Summary

COX-2 inhibitor class warnings of gastrointestinal toxicities are not likely to be removed from the label, Pharmacia Global Prescription Business President Carrie Cox told an April 25 analysts conference call.

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COX-2 inhibitor safety labels

FDA issues "approvable" letter April 6 for Merck's Vioxx (rofecoxib) for the inclusion of updated gastrointestinal safety data in labeling. Pharmacia/Pfizer's Celebrex (celecoxib) receives "approvable" letter April 12. FDA's Arthritis Advisory Committee recommended Feb. 7-8 that Vioxx and Celebrex could incorporate GI safety data in product labels (1"The Pink Sheet" Feb. 19, p. 11)

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