FDA accepts NDA for oxymorphone extended release formulations

Published: 20-Feb-2003

The US FDA has accepted for filing Endo Pharmaceuticals' New Drug Application (NDA) for oxymorphone extended release tablets (oxymorphone ER).


The US FDA has accepted for filing Endo Pharmaceuticals' New Drug Application (NDA) for oxymorphone extended release tablets (oxymorphone ER).

Oxymorphone ER is an oral extended-release opioid analgesic that was jointly developed by Penwest Pharmaceuticals and Endo for the treatment of moderate to severe pain in patients requiring continuous opioid therapy for an extended period of time. The NDA for oxymorphone ER was subnmitted in December 2002.

'We are very pleased with the FDA acceptance of the NDA for oxymorphone ER and look forward to bringing this important new pain product to the market,' said Tod R. Hamachek, Penwest chairman and ceo. 'This NDA acceptance marks a significant milestone in our ongoing effort to establish Penwest as a drug development company.'

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