ARTICLE | Clinical News

Extended-release oxymorphone regulatory update

November 15, 2010 8:00 AM UTC

FDA said it no longer sees a need to convene an advisory committee meeting that was planned for Dec. 2 to discuss an NDA from Endo for an extended-release, crush-resistant formulation of oxymorphone. According to Endo, FDA said it had received sufficient information from previous advisory committee meetings to enable the agency to reach a decision without additional external input. ...