ARTICLE | Company News

FDA wants alcohol warning on Avinza label

July 21, 2005 1:44 AM UTC

FDA requested that Ligand (LGNDE) include stronger warnings about alcohol use on the label of pain drug Avinza morphine sulfate. The agency said that in vitro studies show that alcohol compromises the extended-release characteristics of the drug. LGNDE said it might have to do in vivo pharmacokinetic studies to assess which of the changes FDA requested are appropriate. ...