UPDATE: VIVUS Qnexa PDUFA Date Extended

The U.S. Food andDrug Administration informed VIVUS (Nasdaq: VVUS) of an extendedPrescription Drug User Fee Act date for its review of the Qnexa NewDrug Application from April 17 to July 17, 2012. The three-monthextension is a standard extension period.On April 4, 2012, following the FDA's request, VIVUS submitted the Qnexa RiskEvaluation and Mitigation Strategy, which was considered a majoramendment to the NDA. The submission consisted of proposed REMS materials.Since the receipt date was within three months of the user fee goal date, theFDA is extending the PDUFA date by three months to provide time for a fullreview of the submission.