WASHINGTON (AP) — The makers of a twice-rejected pill designed to boost women's libido are resubmitting their drug to federal health regulators, following a recent lobbying push by politicians, women's groups and consumer advocates.
Sprout Pharmaceuticals says it is refiling its application for the drug, flibanserin, adding new information requested by the Food and Drug Administration about how the pill affects driving ability. FDA scientists requested that data after previous company studies showed nearly 10 percent of women taking the drug reported sleepiness as a side effect.
If approved, Sprout's daily pill would be the first drug for women who report a lack of sexual desire, a market that drugmakers have been trying to break into since the blockbuster success of Viagra for men in the late 1990s.
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