Drug Development

Letter issued from U.S. FDA on Dapoxetine application

Published in Medical Letter on the CDC and FDA, November 27th, 2005

Alza Corp. announced that it has received a not approvable letter from the U.S. Food and Drug Administration (FDA) on their New Drug Application for dapoxetine hydrochloride, an investigational compound for the treatment of premature ejaculation (PE).

Alza Corp. is committed to developing safe and effective medicines that address important unmet medical needs. The company continues to believe that dapoxetine provides important benefits for men who suffer from PE. Alza plans to address questions raised in the FDA letter and continue the global development program.

PE is a distinct medical condition that has been recognized by the American Urological...

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Source: Medical Letter on the CDC and FDA (2005-11-27)

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