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FDA Broadens Labeling for BMS’ Orencia

By Pharmaceutical Processing | August 26, 2009

NEW YORK (AP) — Bristol-Myers Squibb Co. said Wednesday regulators approved a change in the labeling of the rheumatoid arthritis drug Orencia. The FDA approved an addition to the label that says studies show Orencia is effective for patients who have had the disease for two years or less. The Food and Drug Administration approved the drug in late 2005. Its initial label said it was indicated for patients with moderate to severe rheumatoid arthritis who did not respond to treatment with other drugs, such as methotrexate. The drug, with worldwide sales of $129 million in 2008, is designed to reduce symptoms of rheumatoid arthritis. The company requested FDA approval of Orencia as a treatment for “early” rheumatoid arthritis late last year.

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