![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » FDA Advisory Committees Recommend Teva’s Vantrela
FDA Advisory Committees Recommend Teva’s Vantrela
June 13, 2016
Two advisory committees recommended the approval of Teva Pharmaceutical’s Vantrela for pain management with abuse-deterrent labeling.
The committees voted 14-3 to recommend approving the extended-release product for managing severe pain that requires daily opioid treatment in cases when alternative therapies are inadequate.
Committee members largely agreed that the candidate demonstrated a lower increase in pain compared to the placebo in Teva’s Study 3103. Those who voted against approval expressed concerns about introducing another high-dose opioid given the opioid-abuse epidemic.
Upcoming Events
-
21Oct