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VIVUS Provides Regulatory Update on QNEXA
Date:9/15/2011

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About VIVUS VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company's lead investigational product in clinical development, QNEXA®, has completed phase 3 clinical trials for the treatment of obesity and is currently being considered for approval by US and EU regulators. VIVUS received a Complete Response Letter, or CRL, to the initial QNEXA NDA on October 28, 2010. QNEXA is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS has submitted an NDA for avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction. For more information about the company, please visit www.vivus.com.

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate" and "intend," among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the timing and substance of our response to the FDA's requests from the End of Review meeting; our response to, and continued dialogue with, the FDA relating to matters raised in the FDA's CRL; the timing and results of the retrospective observational study of fetal outcomes in infants born to mothers exposed to topiramate during pregnancy or FORTRESS; the FDA's interpretation of and agreement with the information VIVUS submitted and may submit relating to teratogenicity and cardiovascular safety; the FDA's interpretation of the data from our SEQUEL study, or OB-305; the FDA's requests, if any, to cond
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SOURCE VIVUS, Inc.
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1. VIVUS Announces FDA Acceptance of Avanafil New Drug Application for Treatment of Erectile Dysfunction
2. VIVUS Announces $45.8 Million Registered Direct Offering of Common Stock
3. VIVUS Reports Second Quarter and First Six Months 2011 Financial Results
4. VIVUS Reports 2010 Fourth Quarter and Full-Year Financial Results
5. VIVUS to Present at Three Upcoming Investor Conferences in March
6. VIVUS Provides Regulatory Update on QNEXA NDA
7. VIVUS to Present at the 2011 JP Morgan Healthcare Conference
8. VIVUS Submits Briefing Document to FDA, Announces Follow-up Meeting to Discuss QNEXA®
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10. VIVUS Reports Third Quarter and First Nine Months 2010 Financial Results
11. FDA Issues Complete Response Letter to VIVUS Regarding New Drug Application for QNEXA®
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