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VIVUS Submits Briefing Document to FDA, Announces Follow-up Meeting to Discuss QNEXA®
Date:12/14/2010

MOUNTAIN VIEW, Calif., Dec. 14, 2010 /PRNewswire/ -- VIVUS, Inc. (Nasdaq: VVUS) today announced that the company, as part of its continuing effort to secure regulatory approval for QNEXA® in the U.S., submitted a briefing document to the Food and Drug Administration (FDA) designed to address items in the FDA's Complete Response Letter (CRL), issued on October 28, 2010.  The company also announced that the Endocrine and Metabolic Division of the FDA has granted VIVUS a meeting in the second half of January 2011 to discuss the content of the proposed resubmission.

VIVUS is pursuing regulatory approval to market QNEXA (phentermine/topiramate) Controlled Release Capsules in the U.S. for the treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with co-morbidities such as hypertension, type 2 diabetes, dyslipidemia or central adiposity.

"Submission of our briefing document and confirmation of our meeting with the FDA indicate the continued progress VIVUS is making in seeking U.S. approval of QNEXA® for the treatment of obesity," said Leland Wilson, chief executive officer of VIVUS. "We are confident in the data analyses we have compiled in the briefing document, and we look forward to our meeting with the FDA."

About QNEXA Controlled Release Capsules

QNEXA [kyoo-nek-suh] is an investigational drug 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 together decrease appetite and increase satiety (the sense of feeling full), the two main mechanisms that impact eating behavior. In phase 2 and 3 clinical data to date, patients taking QNEXA have demonstrated statistically significant weight loss,
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SOURCE VIVUS, Inc.
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