FDA committees approve Teva Pharmaceutical’s pain management medication: 4 things to know

The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee have recommended the approval of Teva Pharmaceutical’s VANTRELA ER, according to a Street Insider report.

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Here are four things to know:

1. VANTRELA ER is intended to manage severe pain that may require long-term opioid treatment.

2. VANTRELA ER is an extended-release formulation of hydrocodone bitartrate with Teva’s proprietary abuse deterrence technology.

3. The committees also voted that, if approved, Teva Pharmaceutical’s should label the medication an “abuse-deterrent product.”‘

4. While the FDA is not bound by the committees, it will take their decision into consideration.

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