Qnexa complete response letter "manageable" says market as Vivus' stock rises
This article was originally published in Scrip
Executive Summary
Vivus has received an expected complete response letter (CRL) from the US FDA turning down its lead product Qnexa (phentermine/topiramate), its closely watched investigational weight loss drug, because of safety concerns regarding potential teratogenic and cardiovascular risks that had been raised at an FDA advisory committee meeting in July.