FDA Approves Opioid Treatment
The FDA has approved Teva’s Vantrela ER (hydrocodone bitartrate) extended-release tablets, a long-term opioid treatment that is indicated for the management of severe pain for which alternative options are inadequate. Vantrela ER will be available as 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg strength dosages, according to prescribing information.

Vantrela ER’s approval is based on results from a clinical program that evaluated the drug’s safety and efficacy, as well as its abuse potential in laboratory-based in vitro manipulation and extraction studies, pharmacokinetic studies, and clinical abuse potential studies. The drug was formulated with Teva’s proprietary abuse deterrence technology, according to a prepared statement from the company....