Arymo ER morphine sulfate extended-release regulatory update

FDA’s Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees voted 18-1 to recommend approval of Arymo ER morphine sulfate extended-release tablets from Egalet to manage pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate. The PDUFA date is Oct. 14. ...