The U.S. Food and
Drug Administration informed VIVUS 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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