FDA Advisory Committee recommends by 14-3 approval of Vantrela ER (hydrocodone bitartrate extended-release) for the management of severe pain.-Teva

Teva Pharmaceutical Industries Ltd. announced that the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the FDA voted 14 to 3 to recommend approval of Vantrela ER (hydrocodone bitartrate extended-release) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Vantrela ER is an extended-release formulation of hydrocodone bitartrate with Teva�s proprietary abuse deterrence technology.

The committees also voted: 14 to 3 that if approved, Vantrela ER should be labeled as an abuse-deterrent product by the oral route of abuse. 14 to 3 that if approved, Vantrela ER should be labeled as an abuse-deterrent product by the nasal route of abuse. 16 to 1 that if approved, Vantrela ER should be labeled as an abuse-deterrent product by the intravenous route of abuse.