VIVUS, Inc. And Auxilium Pharmaceuticals Announce FDA Acceptance Of Supplemental Filing Seeking An Update Of Prescribing Information For STENDRA (Avanafil)
Published: Jan 21, 2014
MOUNTAIN VIEW, Calif. and CHESTERBROOK, Pa., Jan. 21, 2014 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq:VVUS) and Auxilium Pharmaceuticals, Inc. (Nasdaq:AUXL) 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.
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