Endo Pharmaceuticals (Nasdaq: ENDP) announced today that it received notification from the U.S. Food and Drug Administration (FDA) that Endo's complete response to the FDA's Jan. 7, 2011 Action Letter relating to Endo's new drug application (NDA) 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.
"We are excited about the opportunity to offer this new formulation of OPANA ER designed to be crush resistant," said Ivan Gergel, M.D., executive vice president, R&D, Endo Pharmaceuticals. "Endo remains dedicated to improving patient care and the appropriate clinical use of opioid analgesics through access to treatment and a proactive approach to managing the potential risks inherent in opioid therapy."