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

to the initial QNEXA NDA on October 28, 2010. QNEXA is also in phase 2 clinical development for the treatment of obstructive sleep apnea and type 2 diabetes . In the area of sexual health, VIVUS completed phase 3 development with avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction, and avanafil is currently under review by the FDA. 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," "estimate," "expect," "forecast" 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 QNEXA End-of-Review meeting; our response to, and continued dialogue with, the FDA relating to matters raised in the FDA's QNEXA CRL; the timing and results of the retrospective observational study of fetal outcomes in infants born to mothers exposed to topiramate during pregnancy; 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 conduct additional prospective studies or retrospective observational studies or to provide further analysis of clinical trial data; the review and questions from the EMA and CHMP on the QNEXA MAA; substantial competition; the impact on future sales based on specific indication and contraindications contained in the label and the extent of the Risk Evaluation and Mitigation Strategies program; uncertainties of litigation
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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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