Endo’s Opana ER, Generic Oxymorphone Safety Get US FDA Panel Review
Executive Summary
Advisory committee to discuss data on abuse of Opana ER and generic oxymorphone extended-release and immediate-release products.
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Opana ER: Effort To Expand US Label Might Lead To Withdrawal Due To Abuse Problems
FDA advisory committees will weigh concerns that Endo’s reformulated version of oxymorphone extended-release, which does not contain abuse-deterrent labeling, has shifted preferred non-oral route of abuse from intranasal to intravenous, which carries additional safety risks.
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.