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FDA pulls Oforta approval

April 26, 2012 1:04 AM UTC

FDA Commissioner Margaret Hamburg revoked accelerated approval of Oforta fludarabine from Sanofi (Euronext:SAN; NYSE:SNY) as a second-line therapy to treat B cell chronic lymphocytic leukemia. According to the agency, Sanofi asked FDA to withdraw approval of Oforta, citing a lack of demand and challenges to completing a required postmarketing trial to verify the compound's benefit. ...