Published in Medical Letter on the CDC and FDA, August 8th, 2004
The clinical trial is designed to provide additional safety and efficacy data for oxymorphone extended-release tablets (oxymorphone ER) to support Endo's New Drug Application (NDA) for this developmental product.
Endo, which jointly developed oxymorphone ER with Penwest, said it had submitted the trial protocol to the FDA under the Special Protocol Assessment (SPA) process. Under the...
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