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

On Wednesday, April 5, 2017, 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 19-Yes to 0-No, with one abstention, the approval of  RoxyBond, oxycodone immediate-release (IR) tablets, submitted by Inspirion Delivery Sciences, LLC (IDS) with the proposed indication of management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.