Aventis Arava
Executive Summary
Rheumatoid arthritis disability prevention sNDA withdrawn Feb. 1. FDA plans to review standards for the indication, Aventis says. The Feb. 9 meeting of the FDA Arthritis Drugs Advisory Committee to discuss the new indication for leflunomide has been cancelled
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Arava labeling change
Aventis' discussions with EU's Committee for Proprietary Medicinal Products regarding Arava's effect on the liver could lead to labeling changes, Pharmaceuticals CEO Richard Markham tells analysts during March 2 meeting in London. "We're in discussions with the CPMP about potential revisions in labeling regarding effects of Arava on the liver. I don't expect anything very serious to happen, but the labeling could have a small deterioration." Aventis withdrew its rheumatoid arthritis disability prevention sNDA Feb. 1 (1"The Pink Sheet" Feb. 5, In Brief)
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