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COX-2 inhibitor safety labels

Executive Summary

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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