18 January 2017 - Vantrela ER label describes the product’s abuse-deterrent properties against abuse in the three most common routes—oral, intranasal and intravenous.
Teva Pharmaceutical Industries today announced the U.S. FDA approved Vantrela ER (hydrocodone bitartrate) extended-release tablets formulated with Teva’s proprietary abuse deterrence technology.
Vantrela ER is indicated 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. The product’s approval is supported by a clinical program that evaluated the safety and efficacy of Vantrela ER, as well as its abuse potential in laboratory-based in vitro manipulation and extraction studies, pharmacokinetic studies, and clinical abuse potential studies.