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VIVUS Says FDA Extends Qnexa PDUFA Date

VIVUS Inc. (VVUS) said Monday that the U.S. Food and Drug Administration has extended the Prescription Drug User Fee Act date for its review of the Qnexa New Drug Application by three months from April 17 to July 17, 2012.

On April 4, following the FDA's request, VIVUS submitted the Qnexa Risk Evaluation and Mitigation Strategy, which was considered a major amendment to the NDA. The submission consisted of proposed REMS materials.

Since the receipt date was within three months of the user fee goal date, the FDA is extending the Prescription Drug User Fee Act date by three months to provide time for a full review of the submission, the company noted.

The Qnexa NDA seeks approval for the treatment of obesity, including weight loss and maintenance of weight loss for obese patients with weight-related co-morbidities such as hypertension, type 2 diabetes or dyslipidemia.

by RTT Staff Writer

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