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news.Vivus, a biopharmaceutical company, has received US Food and Drug Administration (FDA) approval for filing and review the New Drug Application (NDA) for Qnexa used in obesity treatment.
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Qnexa is a once-a-day, oral investigational drug candidate which treats weight loss, type 2 diabetes and obstructive sleep apnea.
FDA assigned a six-month, or class 2, review classification to the NDA and declared 17 April 2012, as the Prescription Drug User Fee Act (PDUFA) target date.
The NDA resubmission calls for approval for the treatment of obesity, including weight loss and maintenance of weight loss for obese with weight-related disorders such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity.