VIVUS resubmits NDA for Qnexa
VIVUS has resubmitted the New Drug Application (NDA) for Qnexa to the FDA. The resubmission follows an agreement reached in September 2011 with officials of the endocrine and metabolic division of the FDA on the filing strategy for Qnexa. The NDA resubmission seeks approval for an initial indication for the treatment of obesity, including weight loss and maintenance of weight loss for obese patients or overweight patients with weight-related co-morbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity (abdominal obesity). The proposed labeling for Qnexa includes a contraindication for women of childbearing potential. The NDA resubmission also includes a proposed Risk Evaluation and Mitigation Strategy (REMS).