FDA grants tentative approval for Impax Laboratories' generic Opana ER

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Impax Laboratories, Inc.May 14 2010

Impax Laboratories, Inc. (NASDAQ: IPXL) today confirmed that the U.S. Food and Drug Administration (FDA) has granted tentative approval of the Company's Abbreviated New Drug Application (ANDA) for generic version of Opana® ER (oxymorphone hydrochloride) 5, 7.5, 10, 15, 20, 30 and 40 mg tablets. Endo Pharmaceuticals Inc. markets Opana® ER for the treatment of moderate to severe pain.

According to Wolters Kluwer Health, U.S. sales of Opana® ER tablets were approximately $241 million for the 12 months ended March 31, 2010.

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Impax Laboratories, Inc.

Posted in: Medical Condition News | Pharmaceutical News

Tags: Drug Delivery, Endoplasmic reticulum (ER), Food, New Drug Application, Pain, Pharmaceuticals

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