Xtampza ER oxycodone extended-release regulatory update

FDA’s Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees voted 23-0 to support approval of Xtampza ER oxycodone extended-release from Collegium to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative options are inadequate. The PDUFA date is Oct. 12. ...