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FDA accepts new drug application from Vivus

Drug maker hopes to market avanafil for erectile dysfunction

MOUNTAIN VIEW, Calif. — The Food and Drug Administration has accepted a regulatory approval application for a drug made by Vivus for treating erectile dysfunction.

Vivus said it expected the Food and Drug Administration to complete its review of the application for avanafil by April 29, 2012.

"We are pleased with FDA's acceptance of our NDA," Vivus president Peter Tam said. "If approved, avanafil could be a valuable treatment alternative for the 18 million men in the United States that suffer from ED."

I personally do not see how

I personally do not see how this drug will not be approved. While the FDA makes the supreme judgment, there seems to be little apprehension in its overall efficacy and side effects. The short duration between ingestion and working of the drug seem very favorable compared to other PDE5 inhibitors currently on the market.
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