JUN 7 AADPAC-DSRM

On Tuesday, June 7, 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 14-Yes to 3-No, with no abstentions, the safety and efficacy of VANTRELA ER (hydrocodone bitartrate extended-release (ER) tablets). A new drug application (NDA) was submitted by Teva Branded Pharmaceutical Products R&D, Inc., (Teva) for the full 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.

See the SAC Tracker report