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FDA Approves CelebrexTM

On December 31, 1998, the U.S. Food and Drug Administration (FDA) approved CelebrexTM (celecoxib) for relief of the signs and symptoms of osteoarthritis (OA) and adult rheumatiod arthritis (RA).

In clinical trials sponsored by G.D. Searle & Co. and Pfizer Inc., Celebrex was shown to be as effective as the nonsteriodal anti-inflammatory drug (NSAID) naproxen in treating arthritis pain and inflammation with significantly fewer upper gastrointestinal ulcers than both naproxen and ibuprofen.

Celebrex works by inhibiting an enzyme called COX-2, which plays a role in arthritis pain and inflammation. At therapeutic doses, Celebrex does not inhibit the COX-a enzyme, which helps maintain the normal stomach lining. NSAIDs in general inhibit both COX enzymes, so they treat pain and inflammation but may damage the stomach lining, potentially leading to ulcers in some patients. (more info on COX-2 inhibitors)

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