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Rofecoxib Receives FDA Approval for Treatment of JRA

The U.S. Food and Drug Administration (FDA) has approved rofecoxib (Vioxx®), a Cox-2 selective inhibitor, for the relief of the signs and symptoms of the most common forms of JRA (pauciarticular or polyarticular) in children two years and older and who weigh at least 22 pounds. Juvenile rheumatoid arthritis (JRA) is a debilitating type of arthritis that can occur in throughout childhood. The FDA approval of Vioxx® for JRA was based on the largest JRA study ever conducted, which included 310 pediatric and adolescent patients aged 2 to 17 with active pauciarticular or polyarticular JRA.

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