Pain Management

Pharma company files complete response to U.S. FDA on application for oxymorphone ER

Published in Medical Letter on the CDC and FDA, January 29th, 2006

Penwest Pharmaceuticals Co. (PPCO) announced that Endo Pharmaceuticals Inc., Penwest's partner in the development and commercialization of oxymorphone extended-release tablets (oxymorphone ER), reported that it has filed what Endo believes is a complete response to the U.S. Food & Drug Administration's (FDA) approvable letter on its new drug application (NDA) for the investigational product oxymorphone ER.

Endo also said that, under the Prescription Drug User Fee Act (PDUFA) guidelines, the FDA has 60 days to decide if Endo's submission meets the FDA's criteria for a complete response and, if so, Endo expects that the FDA will issue an action letter for the NDA no later...

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Source: Medical Letter on the CDC and FDA (2006-01-29)

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