VIVUS, Auxilium Announce FDA Acceptance of Supplemental Filing Seeking an Update of Prescribing Information for STENDRA

VIVUS

and Auxilium Pharmaceuticals

today announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental application that proposes to revise the STENDRA™ (avanafil) prescribing information with efficacy and safety information from Study TA-501, entitled "A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men with Erectile Dysfunction." The PDUFA date for the supplemental filing is September 20, 2014.