Vivus' Qnexa Gets "Complete Response" Letter From FDA
This article was originally published in The Pink Sheet Daily
FDA wants more data on risk of birth defects, cardiovascular effects, but doesn't ask for new clinical trials - at least for now.
You may also be interested in...
A Risk Evaluation and Mitigation Strategy for Qsymia includes prescriber education about the risk of birth defects and limits dispensing to specially certified pharmacies
Arena’s Belviq is the first obesity drug approval in over a decade, but it won’t be the only one for long. A look at the FDA-approved labeling for lorcaserin offers a preview of how the agency could handle similar issues for Qnexa and, further down the line, Contrave.
New developments for Vivus’ weight loss drug Qnexa may mean that the regulatory environment for obesity treatments could be improving.