FDA Accepts Endo Pharmaceuticals' Complete Response for New Formulation of OPANA ER

Endo Pharmaceuticals

announced today that it received notification from the U.S. Food and Drug Administration that Endo's complete response to the FDA's Jan. 7, 2011 Action Letter relating to Endo's new drug application for a new formulation of OPANA ER has been accepted. The new formulation was developed in partnership with Grunenthal GmbH and is designed to provide some resistance to certain types of product manipulation. FDA has set a Prescription Drug User Fee Act (PDUFA) date of Dec. 13, 2011.