BioCentury
ARTICLE | Clinical News

Oforta fludarabine regulatory update

April 30, 2012 7:00 AM UTC

FDA Commissioner Margaret Hamburg revoked accelerated approval of Oforta fludarabine from Sanofi 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 commercial demand and significant challenges to completing a required postmarketing trial to verify the compound's benefit. ...