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Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management Advisory Committees

On Wednesday, June 8, 2016, the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management (DSRM) Advisory Committee  jointly supported, by a vote of 9-Yes to 6-No, with no abstentions, the safety and efficacy of Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride extended-release (ER) capsules). A new drug application (NDA 207621) was submitted by Pfizer for the proposed indication of the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The Committees also voted in regard to proposed abuse-deterrent labeling claims.