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VIVUS Announces FDA Acceptance of Avanafil New Drug Application for Treatment of Erectile Dysfunction
Date:9/1/2011

and intellectual property and patent protection; reliance on sole-source suppliers; limited sales and marketing resources and dependence upon third parties; risks related to the development of innovative products; risks related to the failure to obtain FDA or foreign authority clearances or approval; noncompliance with FDA or foreign regulations; and our dependence on the performance of our collaborative partners. As with any pharmaceutical in development, there are significant risks in the development, the regulatory approval, and commercialization of new products. There are no guarantees that our response to the FDA's CRL on QNEXA or the results of the retrospective observational study of fetal outcomes in infants born to mothers exposed to topiramate during pregnancy and subsequent meetings and communications will be sufficient to satisfy the FDA's safety concerns, that the FDA will not require us to conduct any additional  prospective studies or retrospective observational studies, or that any product will receive regulatory approval for any indication or prove to be commercially successful. There is no guarantee that the FDA will approve our NDA for avanafil as a treatment of ED.  VIVUS does not undertake an obligation to update or revise any forward-looking statements. Investors should read the risk factors set forth in VIVUS' Form 10-K for the year ending December 31, 2010, and periodic reports filed with the Securities and Exchange Commission.CONTACT:VIVUS, Inc.Investor Relations:The Trout GroupTimothy E. MorrisBrian Korb Chief Financial Officer646-378-2923650-934-5200
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Related medicine technology :

1. VIVUS Announces $45.8 Million Registered Direct Offering of Common Stock
2. VIVUS Reports Second Quarter and First Six Months 2011 Financial Results
3. VIVUS Reports 2010 Fourth Quarter and Full-Year Financial Results
4. VIVUS to Present at Three Upcoming Investor Conferences in March
5. VIVUS Provides Regulatory Update on QNEXA NDA
6. VIVUS to Present at the 2011 JP Morgan Healthcare Conference
7. VIVUS Submits Briefing Document to FDA, Announces Follow-up Meeting to Discuss QNEXA®
8. VIVUS to Present at Two Upcoming Investor Conferences
9. VIVUS Reports Third Quarter and First Nine Months 2010 Financial Results
10. FDA Issues Complete Response Letter to VIVUS Regarding New Drug Application for QNEXA®
11. VIVUS Announces Sale of MUSE Assets to Meda
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