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Vivus/Auxilium seek prescribing change for Stendra

This article was originally published in Scrip

Executive Summary

The FDA has accepted for review a supplemental application from Vivus and its partner Auxilium Pharmaceuticals seeking to revise the prescribing information for Stendra (avanafil) with efficacy and safety information from study TA-501, a randomized, double-blind, placebo-controlled evaluation of the drug for on-demand treatment in men with erectile dysfunction.


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