FDA Approves Celebrex for Treatment of Juvenile Rheumatoid Arthritis




ROCKVILLE, Md. - Pfizer Inc.'s COX-2 inhibitor Celebrex has received U.S. approval for the treatment of juvenile rheumatoid arthritis in patients 2 years of age and older, the FDA said Dec. 15.

The federal agency's decision came just 2-1/2 weeks after the FDA's Arthritis Advisory Committee voted 15-1 in favor of approving the painkiller for JRA, finding that the benefits of Celebrex outweigh the risks.

The committee of outside doctors and other specialists on Nov. 29 unanimously determined that Celebrex is an effective treatment for JRA, but voted 8-7, with one abstention, that available data did not clearly establish that …






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