The FDA has approved Vantrela ER (hydrocodone bitartrate, Teva) extended-release tablets [CII] with Teva’s proprietary abuse deterrence technology targeting oral, intranasal and IV routes. Vantrela ER is indicated to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
A clinical program substantiated the product’s approval through evaluations of the safety and efficacy of Vantrela ER and