ALZA receives non approval letter from FDA for dapoxetine
Friday, October 28, 2005 10:00 IST Mountain View, California
ALZA Corporation has received a non-approvable letter from the US Food and Drug Administration on its new drug application for dapoxetine hydrochloride, an investigational compound for the treatment of premature ejaculation (PE).
PE is a distinct medical condition that has been recognised by the American Urological Association (AUA), the American Psychiatric Association (APA) and the World Health Organisation (WHO). PE can have a significant impact on many aspects of a man's life, including his and his partner's sexual satisfaction, the ability to build and maintain relationships and a general sense of confidence. Currently, there are no drugs approved by the FDA for the treatment of PE. Traditional methods of PE treatment rely heavily on behavioural therapy and off-label use of older drugs that are approved for other conditions, all of which yield limited success, states a company release.
ALZA Corporation 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 Corporation plans to address questions raised in the FDA letter and continue the global development programme.
ALZA Corporation is a leading the next generation of drug delivery, with the world's broadest array of technology platforms, including oral, transdermal, implantable and liposomal technologies. More than 30 products marketed in over 80 countries worldwide now incorporate ALZA Corporation's drug delivery technologies.
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