PPD: FDA rejects new drug application for dapoxetine

SAN FRANCISCO (AFX) -- PPD Inc. and Alza Corp., a unit of Johnson & Johnson , said Wednesday that the Food and Drug Administration has issued a not-approvable letter for their new drug application for dapoxetine for the treatment premature ejaculation. The letter was sent to Alza, which has a licensing agreement for dapoxetine with PPD. Alza said in a separate release that it plans to address questions raised by the FDA. Alza didn't outline why the FDA rejected the application. Alza also said it plans to continue the global development of dapoxetine, and believes that it provides important benefits to men who suffer from premature ejaculation.

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