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FDA Accepts Endo Pharmaceuticals' Complete Response for New Formulation of OPANA® ER
Date:6/23/2011

CHADDS FORD, Pa., June 23, 2011 /PRNewswire/ -- 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."

Important information about OPANA® ER

OPANA ER is indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time and is not intended for use as an as needed analgesic.

OPANA ER is not indicated for pain in the immediate post-operative period (12-24 hours following surgery) for patients not previously taking opioids because of the risk of over sedation and respiratory depression requiring reversal with opioid antagonists. OPANA ER is not indicated for pain in the post-operative period if the pain is mild or not expected to persist for an extended period of time.

OPANA® ER has a boxed warning as follows:

WARNING: OPANA ER contains oxymorphone, which is a morphine-like opioid agonist and a Schedule II controlled substance, with an abuse liability similar to oth
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SOURCE Endo Pharmaceuticals
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