Aventis Discussing Arava Label Changes With FDA; EU Revises Monitoring
Executive Summary
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.
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Aventis is working with FDA to update Arava labeling based on postmarketing information from methotrexate combination studies on the rheumatoid arthritis drug
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)