Federal health advisers are refusing to recommend a hormone patch that works to restore a woman's sex drive.
An advisory committee says the patch, called Intrinsa, shouldn't win government approval until more studies are completed to determine the drug's risks.
Several members of the FDA committee said they weren't satisfied with the number of women studied so far, the length of the studies and the modest benefits of the drug.
Procter and Gamble sought to market the testosterone patch to women who lost their libido after their ovaries were removed. The company said in a statement it would work closely with the agency "to agree on a practical approach to provide additional safety data."
The FDA isn't bound by the committee's recommendation, although the agency usually follows the guidance.