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January 21, 2014
07:13 EDTVVUS, AUXLVIVUS and Auxilium announces FDA accepted STENDRA's supplemental application
VIVUS (VVUS) and Auxilium Pharmaceuticals (AUXL) announced that the FDA has accepted a supplemental application that proposes to revise the STENDRA, or 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.
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