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.
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.
