Market Overview

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

VIVUS (Nasdaq: VVUS) and Auxilium Pharmaceuticals (Nasdaq: AUXL) today announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental application that proposes to revise the STENDRAâ„¢ (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.

See full press release

Posted-In: News Guidance Offerings FDA Management M&A Global


Most Popular

Related Articles (AUXL + VVUS)

Around the Web, We're Loving...

Partner Network

Get Benzinga's News Delivered Free