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ALZA told dapoxetine not approvable
New York, Oct. 26 - ALZA Corp. said the U.S. Food and Drug Administration has told it that its New Drug Application for dapoxetine hydrochloride is not approvable.
Dapoxetine is an investigational compound for the treatment of premature ejaculation.
ALZA said it continues to believe that dapoxetine provides "important benefits" for men who suffer from premature ejaculation and plans to address the questions raised by the FDA and continue a global development program.
The Mountain View, Calif., pharmaceutical company noted that there are currently no drugs approved by the FDA to treat premature ejaculation.
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