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.
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Earlier Event: June 7Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management Advisory Committees
Later Event: June 9Antimicrobial Drugs Advisory Committee