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Bextra "not approvable" for migraine

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Pfizer's COX-2 inhibitor Bextra (valdecoxib) is "not approvable" for treatment of migraine as of August, Pfizer's Nov. 5 10-Q filing with the Securities & Exchange Commission states. Bextra faces another setback with the expected addition of a "black box" warning to labeling regarding skin reactions. "Revised labeling for the product…will likely include the addition of a black box," the SEC filing says. The firm's Oct. 15 "Dear Doctor" letter also includes a discussion of Bextra's cardiovascular safety profile. Data showing an apparent increased risk in CV events in two studies in high-risk surgery patients were presented at the American Heart Association meeting Nov. 9...

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