UPDATE: VIVUS Qnexa PDUFA Date Extended
The U.S. Food and Drug Administration informed VIVUS (Nasdaq: VVUS) of an extended Prescription Drug User Fee Act date for its review of the Qnexa New Drug Application from April 17 to July 17, 2012. The three-month extension is a standard extension period.
On April 4, 2012, 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 PDUFA date by three months to provide time for a full review of the submission.
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