Dapoxetine
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Dapoxetine used for the treatment of PE (premature ejaculation) in men 18-64 years old. In a phase II proof-of-concept study conducted by PPD, dapoxetine demonstrated a statistically significant increase in ejaculatory latency when compared to placebo. Alza submitted an NDA to the FDA for dapoxetine for the treatment of premature ejaculation in December 2004. In October 2005, the company received an FDA Non-Approvable letter from the FDA, at which time they planned to work with regulators to address outstanding questions.
