Endo Pharmaceuticals Holdings Inc. (ENDP) said the U.S. FDA has informed that there is no need to convene a joint meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to review Endo's New Drug Application for the new oral formulation of long-acting oxymorphone.
FDA has also informed that it has gleaned sufficient information from previous advisory committee meetings to enable the division to reach a decision on the company's application without additional external expert input.
The new formulation of long-acting Oxymorphone designed to be crush-resistant, is a semi-synthetic opioid analgesic intended for the treatment of moderate to severe chronic pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.
The action date set by FDA under the Prescription Drug User Fee Act is Jan. 7, 2011.
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