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FDA approves Teva’s Vantrela ER


SILVER SPRING, Md. — The Food and Drug Administration has approved Teva’s Vantrela ER (hydrocodone bitartrate, extended-release) tablets, the company announced Wednesday. The drug, indicated for pain severe enough to require daily, around-the-clock, long-term opioid treatment and patients for whom alternative therapy is inadequate, is formulated with Teva’s proprietary abuse-deterrent technology. 


“Teva understands the risk of prescription drug abuse is a challenge healthcare professionals face when treating millions of Americans affected by chronic pain,” Teva president and CEO of global specialty medicines Dr. Rob Koremans said. “Abuse-deterrent treatments provide options for prescribers that may help deter or mitigate abuse while still preserving access to pain medications for the patients that need them most.”


Vantrela ER’s abuse-deterrent properties are expected to reduce, but not totally prevent oral, intravenous and intranasal abuse of the drug when tablets are manipulated. As an opioid, Vantrela ER comes with a boxed warning that includes addiction, abuse and misuse, which can lead to overdose and death, as well as serious, life-threatening or fatal respiratory depression. 


“While no technology can completely eliminate abuse, Teva’s proprietary abuse deterrence technology is an important step forward,” Teva president of global R&D and chief scientific officer Dr. Michael Hayden said. “We are committed to furthering responsible pain management.”


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