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news.The US Food and Drug Administration (FDA) has informed Endo Pharmaceuticals that it no longer sees a 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 (NDA) for the new oral formulation of long-acting oxymorphone.
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Endo said that, 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 and was developed in partnership with Grunenthal.
Endo Research and Development executive vice president Ivan Gergel said that FDA has informed them that it has gleaned sufficient information from previous advisory committee meetings to enable the division to reach a decision on their application without additional external expert input.
Endo stated that the action date set by FDA under the prescription drug user fee act (PDUFA) is 7 January 2011.