Sprout Pharmaceuticals said Wednesday it has reached an impasse with the Food and Drug Administration over its drug, flibanserin. The daily pill is designed to increase libido in women by acting on brain chemicals linked to mood and appetite.
The FDA questions whether the drug's benefits outweigh its risks, considering its "modest" effectiveness and side effects including fatigue, dizziness and nausea.
Sprout said it's appealing an October letter from the FDA that denied approval and asked for more information. But chances for approval appear slim: Of the 17 appeals FDA considered last year, 14 were denied, according to government figures.
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