Teva's Vantrela Gets FDA Panel Nod For Three Abuse-Deterrent Claims
This article was originally published in The Pink Sheet Daily
Hydrocodone extended-release product is an incremental improvement in deterring oral, intranasal and intravenous abuse, committee says.
You may also be interested in...
Pending arrival of several new products prompts evaluation of class, ICER CSO Dan Ollendorf explains; availability of both abuse-deterrent and non-abuse-deterrent drugs among challenging issues.
As Egalet's Arymo ER heads to panel, agency tries to head off discussion about whether it should be approving new opioid products and whether longer clinical efficacy trials should be demanded.
AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.