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FDA Statement

FOR IMMEDIATE RELEASE
Statement
December 20, 2004

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FDA Statement on Celebrex DTC Promotion

On December 17, FDA asked Pfizer, Inc. to voluntarily suspend DTC advertising on Celebrex during the time the Agency is obtaining and evaluating the new and conflicting scientific data on adverse events associated with the drug. FDA also requested the company change the information provided to physicians to reflect the recommendations FDA made encouraging physicians to consider alternative therapies as they evaluate their individual patient needs.

Pfizer agreed to the broad suspension of its Celebrex promotion and to craft appropriate detailing to physicians that reflects the uncertainty of scientific data currently available.

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