Additional Relevant Details FDA voted 14 to 3 to recommend approval of VANTRELA™ ER 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.