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FDA's COX-2 Safety Plan: Remove Bextra, Add "Black Box" To Celebrex

This article was originally published in The Pink Sheet Daily

Executive Summary

Pfizer has not yet agreed to withdraw Bextra but will suspend marketing pending further discussions with FDA. Boxed warning on all prescription NSAIDS – including Celebrex – will discuss increased cardiovascular and gastrointestinal risk. FDA's decision comes two days after Pfizer tells analysts COX-2 inhibitor sales are stabilizing.

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EMEA Gives Pfizer One Year To Provide Data For Bextra Reintroduction

European Medicines Agency concludes its review of the COX-2 class with formal recommendation to remove Bextra from the market and additional contraindications and warnings for class labeling. The agency will now turn its attention to the safety profile of “some conventional” NSAIDs.

EMEA Gives Pfizer One Year To Provide Data For Bextra Reintroduction

European Medicines Agency concludes its review of the COX-2 class with formal recommendation to remove Bextra from the market and additional contraindications and warnings for class labeling. The agency will now turn its attention to the safety profile of “some conventional” NSAIDs.

GSK Approval Plan For COX-2 Inhibitor Includes Lower Doses In Phase III

The company will experiment with lower doses of its COX-2 inhibitor, 406381, to mitigate the cardiovascular risk seen with the class, CEO Garnier says. While FDA has “blessed” GSK’s Phase III program, testing multiple doses will give GSK “more chances to win.” The agency is also asking for a cardiovascular safety study.

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