VIVUS, Inc. (VVUS) said Thursday that the U.S. Food and Drug Administration has accepted for filing and review the New Drug Application for Qnexa to treat obesity.
The company resubmitted the NDA on October 17. The NDA resubmission seeks approval 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. The FDA has assigned a six-month, or class 2, review classification to the NDA, establishing April 17, 2012, as the Prescription Drug User Fee Act target date.
According to the company, the agency has indicated that an advisory committee of the Division of Metabolism and Endocrinology Products will meet to discuss the Qnexa NDA in the first quarter of 2012.
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