FDA Wants More Info On Sprout Pharmaceuticals's Female Libido Pill
Published: Feb 11, 2014
The U.S. Food and Drug Administration has denied an appeal by Sprout Pharmaceuticals to approve its experimental drug for low female sexual desire but offered a potential pathway to approval, the company said on Tuesday. The FDA has asked for three additional studies, two to test the drug's interaction with other drugs, and a third to simulate driving since nearly 10 percent of women in clinical trials became sleepy while taking the drug, flibanserin. Privately held Sprout said it welcomed the FDA's guidance and views it as "a significant step" toward approving flibanserin, a once-a-day treatment for hypoactive sexual desire disorder (HSDD).
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