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Celebrex, Bextra Stabilizing After FDA Advisory Committee Review, Pfizer Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Company is predicting a return to growth in the COX-2 category once FDA completes work on new labeling. Celebrex and Bextra "will remain critical treatment options for many years to come," Pfizer tells analysts.

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Silver Lining For Pfizer? Celebrex Well-Positioned In NSAID Class

The boxed warning for Pfizer's Celebrex will differ only slightly from labeling for other prescription NSAIDs, FDA says. All products will bear new language addressing increased cardiovascular and gastrointestinal risks. The agency appears open to renewed direct-to-consumer advertising for Celebrex.

Celebrex Long-Term Safety Study Planned

Pfizer will work with FDA to design a long-term safety study for Celebrex following the agency's decision to recommend a "black box" warning on the COX-2 inhibitor's increased risk for cardiovascular events

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

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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