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Bextra "Likely" To Add Black Box Warning, Pfizer Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Pfizer expects that resolution of labeling discussions with FDA will include boxed warning about skin reactions. FDA will have to consider whether to handle issue in context of broader COX-2 class safety review.

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Pfizer is characterizing FDA's request for a withdrawal of Bextra as a "marketing suspension"; the company hopes to continue discussions on how valdecoxib could re-enter the market. Increased cardiovascular risk plus a "special risk" of serious skin reactions led FDA to recommend pulling the COX-2 inhibitor.

Bextra Pulled From Market, But Pfizer Hopes To Explore Other Options

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