FDA rejects J&J premature ejaculation drug
The FDA has rejected Johnson & Johnson's application for its experimental drug to treat premature ejaculation, the company said yesterday.
J&J's Alza unit said it plans to address the questions raised by the FDA in its not approvable letter and continue developing the drug.
Alza did not provide further details on why the FDA did not approve the drug.
In a statement, the J&J unit said it "continues to believe that dapoxetine provides important benefits for men who suffer from (premature ejaculation)."
Currently, there are no FDA approved drugs on the market to treat premature ejaculation, a distinct medical condition recognized by the American Urological Association, among other groups.