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FDA Advisory Committee Recommends Approval of Qnexa®
Date:2/22/2012

MOUNTAIN VIEW, Calif., Feb. 22, 2012 /PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS) today announced that the U.S. Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee recommended Qnexa be granted marketing approval by the FDA for the treatment of obesity in adults. The Committee voted 20 to 2, on the recommendation for an approval based on a favorable benefit-risk profile.

"We are pleased with the panel's approval recommendation in support of the safety and efficacy of Qnexa," said Peter Tam, President of VIVUS. "We look forward to working with the FDA as they complete their evaluation. Obesity is a serious medical condition, and we are committed to making Qnexa available and providing physicians with a new medical treatment option in their battle with this public health epidemic."

The FDA is not bound by the recommendations of its advisory committees, but will consider the guidance during the review of the New Drug Application (NDA) that was submitted for Qnexa in October 2011. The scheduled Prescription Drug User Fee Act (PDUFA) date for Qnexa is April 17, 2012.Note to InvestorsVIVUS will hold a conference call to discuss this update today, February 22, 2012, beginning at 6:30 p.m. Eastern Time. You can listen to this call by dialing toll free 877-359-2916 or 224-357-2386. A 30-day archive of the call can be accessed at http://ir.vivus.com/.

About Qnexa Controlled Release CapsulesQnexa [kyoo-nek-suh] is an investigational drug candidate being developed to address weight loss, type 2 Diabetes and obstructive sleep apnea. Qnexa is a once-a-day, proprietary, oral, controlled-release formulation of low-dose phentermine and topiramate, which is designed to decrease appetite and increase satiety (the sense of feeling full), the two main mechanisms that impa
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SOURCE VIVUS, Inc.
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