FDA accepts Endo's harder-to-abuse Opana ER application, with six-month review set
This article was originally published in Scrip
Executive Summary
Endo Pharmaceuticals said that it has been notified by the US FDA that the agency has accepted its complete response which was filed to address concerns of the agency in its January Action Letter rejecting the harder-to-abuse formulation of the extended-release oxymorphone drug Opana ER.