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VIVUS Provides Qnexa Regulatory Update
Date:1/9/2012

of sexual health, VIVUS has submitted an NDA for avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction, with an FDA action date of April 29, 2012.  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, or central adiposity (abdominal obesity), with a contraindication that excludes the use of Qnexa by women who are pregnant; the timing and results of the retrospective observational study of fetal outcomes in infants born to mothers exposed to topiramate during pregnancy, or the FORTRESS study; the reliability of the electronic medical claims healthcare databases used in the FORTRESS study; the FDA's interpretation of and agreement with the information VIVUS submitted relating to teratogenicity and cardiovascular safety; the FDA's interpretation of the data from our SEQUEL study (OB-305) and Sleep Apnea study (OB-204); that we may be required to provide further analysis of clin
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