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Vivus Announces FDA Approval Of STENDRA™ (avanafil) Tablets For The Treatment Of Erectile Dysfunction

Stocks in this article: VVUS

Drinking too much alcohol when taking STENDRA may lead to headache, dizziness, and lower blood pressure.

STENDRA in combination with other treatments for ED is not recommended.

STENDRA does not protect against sexually transmitted diseases, including HIV.

The most common side effects of STENDRA are headache, flushing, runny nose and congestion.

Please see full patient prescribing information for STENDRA (50 mg, 100 mg, 200 mg) tablets.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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. Vivus resubmitted the Qnexa NDA in October 2011, which has a FDA action date of July 17, 2012. On February 22, 2012, in a 20-to-2 vote, the U.S. Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee recommended that Qnexa be granted marketing approval by the FDA for the treatment of obesity in adults. Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. 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,"  "expect," "intend,"  "likely," "may," "plan," "potential," "predict," "opportunity" and "should," 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 response from the United States Food and Drug Administration, or FDA, to our resubmission of the New Drug Application, or NDA, for Qnexa for the treatment of obesity, including weight loss and maintenance of weight loss, recommended for obese patients (BMI ≥30 kg/m2), or overweight patients (BMI ≥27 kg/m2) with weight-related co-morbidities such as hypertension, type 2 diabetes, dyslipidemia, with a contraindication that excludes the use of Qnexa by women who are pregnant; the timing and final results of the retrospective observational study of fetal outcomes in infants born to mothers exposed to topiramate during pregnancy, or FORTRESS; the reliability of the electronic medical claims healthcare databases used in FORTRESS; the FDA's interpretation of and agreement with the information VIVUS submitted relating to teratogenicity and cardiovascular safety; that we may be required to provide further analysis of clinical trial data; our response to questions and requests for additional information including additional pre-clinical or clinical studies from the European Medicines Agency, or EMA, and the Committee for Medicinal Products for Human Use, or CHMP, of the Marketing Authorization Application, or MAA, for Qnexa; the FDA's interpretation of the results of external studies to assess the teratogenic risk of topiramate; the impact of the results of the REMS or cardiovascular outcomes for obesity advisory committee meetings; whether or not the FDA chooses to follow the recommendation of the second advisory committee in its vote in favor of approval of Qnexa; the impact, if any, of the agreement and initiation by one of our competitors with an obesity compound to conduct or complete a cardiovascular outcomes study pre-approval; the impact on future sales based on specific indication and contraindications contained in the label and extent of the REMS and distribution system and patient access program for Qnexa, if approved; our ability to successfully commercialize or establish a marketing partnership for STENDRA or our partner's ability to obtain and maintain regulatory approval to manufacture and adequately supply STENDRA for commercial use; our history of losses and variable quarterly results; substantial competition; risks related to the failure to protect our intellectual property and litigation in which we may become involved; uncertainties of government or third party payer reimbursement; our reliance on sole source suppliers; our limited sales and marketing and manufacturing capabilities; our reliance on third parties and our collaborative partners; failure to continue to develop innovative investigational drug candidates and drugs; risks related to the failure to obtain FDA or foreign authority clearances or approvals and noncompliance with FDA or foreign authority regulations; our ability to demonstrate through clinical testing the safety and effectiveness of our investigational drug candidates; the timing of initiation and completion of clinical trials and submissions to the FDA or foreign authorities; the volatility and liquidity of the financial markets; our liquidity and capital resources; our ability to successfully create a commercial infrastructure in the United States to launch Qnexa; and our expected future revenues, operations and expenditures.  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 or CHMP's 180-day list of outstanding issues, the FDA's requests stemming from the end-of-review meeting or the results of the FORTRESS study and subsequent meetings and communications will be sufficient to satisfy the FDA or CHMP's safety concerns, that the FDA or foreign authorities 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.  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, 2011, and periodic reports filed with the Securities and Exchange Commission.



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