Rheumatoid arthritis disability prevention sNDA withdrawn Feb. 1.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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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)
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011