FDA Moves On Endo’s Opana ER Unlikely To Sweep Up Other Opioids
Shift toward intravenous abuse with the reformulated long-acting opioid, coupled with reports of a serious bleeding disorder and HIV transmission, spurred US FDA advisory committee to recommend regulatory action, which could include new labeling, strict risk management measures or market withdrawal.
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Concerns that the extended-release oxycodone product poses the same potential for intravenous abuse as Endo’s withdrawn Opana ER drive FDA advisory committee recommendation against approval, laying the groundwork for a fourth complete response letter; FDA’s comparison of Remoxy to Opana during the meeting ‘borders on slanderous,’ PTI CEO Barbier tells Scrip, predicting sponsors will be dissuaded by the shifting regulatory goalposts for abuse-deterrent formulations.
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