Arava labeling change
Executive Summary
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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Aventis Discussing Arava Label Changes With FDA; EU Revises Monitoring
Aventis is in discussions with FDA regarding labeling changes for Arava (leflunomide) to reflect reports of hepatic injury associated with use of the rheumatoid arthritis therapy.
Aventis Discussing Arava Label Changes With FDA; EU Revises Monitoring
Aventis is in discussions with FDA regarding labeling changes for Arava (leflunomide) to reflect reports of hepatic injury associated with use of the rheumatoid arthritis therapy.
Aventis Arava
Rheumatoid arthritis disability prevention sNDA withdrawn Feb. 1.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