Vivus' Erectile Dysfunction Drug Stendra Wins FDA Approval

Law360, New York (April 27, 2012, 8:00 PM EDT) -- The U.S. Food and Drug Administration on Friday approved Vivus Inc.'s erectile dysfunction pill Stendra, the first erectile dysfunction treatment to be allowed for use in the U.S. in a decade and the first drug to be approved for the company.

The FDA approved Stendra, also known as avanafil, for prescription use for men suffering from erectile dysfunction on an as-needed basis at least 30 minutes before sexual activity.

The drug's safety was established in three double-blind, placebo-controlled clinical studies, the FDA said. A total of...
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