Vivus and Auxilium announce FDA approval of Stendra sNDA; Stendra now first and only oral erectile dysfunction treatment approved to be taken approximately 15 minutes before sexual activity

FDA

VIVUS, Inc. and Auxilium Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Stendra (avanafil). Stendra is now the only FDA-approved erectile dysfunction (ED) medication indicated to be taken as early as approximately 15 minutes before sexual activity.

Stendra is a prescription medication in a class of drugs known as phosphodiesterase type 5 (PDE5) inhibitors approved for the treatment of ED in men 18 years or older. Stendra is available in multiple dosage strengths (50, 100 and 200 mg tablets) and may be taken with or without food and moderate alcohol consumption (up to three drinks). In clinical studies, when compared to placebo, Stendra helped more men achieve an erection in as early as approximately 15 minutes that lasted long enough to successfully complete sexual intercourse.

For more details, go to: http://ir.auxilium.com/phoenix.zhtml?c=142125&p=irol-newsArticle&ID=1969221&highlight=

Michael Wonder

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Michael Wonder

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