Mallinckrodt's Abuse Deterrent Oxycodone IR Narrowly Wins US FDA Panel Backing

Nov 15 2018

• By Brenda Sandburg

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"Incremental" step forward is sufficient for product to be labeled as deterring abuse by nasal, but not intravenous route, advisory committee members conclude.

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A US FDA advisory panel voted 10-7 for approval of Mallinckrodt PLC's abuse deterrent formulation of immediate release oxycodone, concluding that it offered an incremental but sufficient benefit over the non-abuse deterrent product. However, members voted that it should be labeled only as deterring abuse by the nasal route, not the intravenous route.

The Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee considered Mallinckrodt's product,...

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