Pain Medicine

U.S. FDA approves protocol for oxymorphone extended-release tablets

Published in Medical Letter on the CDC and FDA, December 26th, 2004

Endo Pharmaceuticals, Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings, Inc., (ENDP), announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the protocol relating to its developmental product, oxymorphone extended-release tablets (oxymorphone ER), under the FDA's special protocol assessment (SPA) process.

"We are pleased by the FDA's decision, which clears the way for us to begin enrolling patients in this clinical trial," said Carol A. Ammon, chairman and chief executive officer. "We now believe we will be in a position to file our complete response to the FDA's approvable letter for oxymorphone ER in early...

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Source: Medical Letter on the CDC and FDA (2004-12-26)

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