Vivus Would Market Qnexa With Pregnancy Category X Designation If Approved
This article was originally published in The Pink Sheet Daily
Executive Summary
With a strict REMS its only possible future, the weight-loss drug is unaffected by FDA decision to reclassify the topiramate portion of the combination drug as Pregnancy Category D.
You may also be interested in...
Vivus Will Cut Population In Qnexa Resubmission
The biotech announces it will resubmit its obesity drug by the end of October, two months ahead of schedule, after a meeting with FDA.
Vivus Will Cut Population In Qnexa Resubmission
The biotech announces it will resubmit its obesity drug by the end of October, two months ahead of schedule, after a meeting with FDA.
Obesity Drug Developers Aim To Navigate Regulatory Backroads
The major lesson of FDA’s serial rejection of three obesity drugs in a six-month span is that safety is paramount in the weight loss space. That’s agreed. But beyond that, it’s tough to know what to expect, and obesity drug developers face an uncertain regulatory path going forward.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: