Vantrela ER (hydrocodone bitartrate) approved by FDA for management of pain- Teva
Teva Pharmaceutical has announced the FDA approved Vantrela ER (hydrocodone bitartrate) extended-release tablets [CII] 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 (CAP) studies. Adverse reactions in at least 2% of patients in placebo-controlled trials include nausea, constipation, headache, somnolence, vomiting, dizziness, pruritus, fatigue, dry mouth, diarrhea, insomnia, and anxiety.
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