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VIVUS Reports Second Quarter and First Six Months 2011 Financial Results
Date:8/1/2011

om this study will be used as part of the QNEXA New Drug Application (NDA) resubmission to the U.S. Food and Drug Administration (FDA).

The Marketing Authorization Application (MAA) for QNEXA was submitted to the European Medicines Agency (EMA) in December 2010.  In May of 2011 we received the 120-day list of questions from the Committee for Medicinal Products for Human Use (CHMP) and began preparing our response.  The questions and issues raised by the CHMP were consistent with those raised by the FDA.  We have requested and have been granted a meeting with the rapporteur September 2011 to discuss the 120-day questions.  The purpose of this meeting is to provide clarification to certain questions to assist us in preparing our response.  Our response to the 120-day questions is expected in the fourth quarter of 2011.

"The FORTRESS protocol has been reviewed and approved by the FDA.  The results of the retrospective study announced in July 2011 and Danish study published in the May 2011 issue of the Journal of the American Medical Association both concluded that topiramate was not a major teratogen. We look forward to the FORTRESS results and resubmission of the QNEXA NDA in the fourth quarter of 2011," stated Peter Tam, president of VIVUS.

Avanafil UpdateIn June 2011, we submitted an NDA to the FDA seeking approval of avanafil, our investigational drug for the treatment of erectile dysfunction (ED). The NDA submission follows the successful completion of an extensive phase 3 program for avanafil, which included over 1,350 patients, where avanafil was shown to be well tolerated and effective in treating men with ED.

"The highlight of the second quarter was the filing of the NDA for avanafil.  Congratulations to all of the members of the avanafil development team who worked diligently to achieve this significant corporate milestone.  In a large and growing market, avanafil, if approved, shou
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SOURCE VIVUS, Inc.
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Related medicine technology :

1. VIVUS Reports 2010 Fourth Quarter and Full-Year Financial Results
2. VIVUS to Present at Three Upcoming Investor Conferences in March
3. VIVUS Provides Regulatory Update on QNEXA NDA
4. VIVUS to Present at the 2011 JP Morgan Healthcare Conference
5. VIVUS Submits Briefing Document to FDA, Announces Follow-up Meeting to Discuss QNEXA®
6. VIVUS to Present at Two Upcoming Investor Conferences
7. VIVUS Reports Third Quarter and First Nine Months 2010 Financial Results
8. FDA Issues Complete Response Letter to VIVUS Regarding New Drug Application for QNEXA®
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