In Recommending Flibanserin Approval, FDA Panelists Urge Alcohol Contraindication
Panel’s vote to approve Sprout’s female sexual dysfunction drug is conditioned on a REMS and possible contraindication with alcohol use; questions about drug’s date rape potential, breast cancer finding in mice addressed.
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In sharp disagreement, FDA says postmarketing trial shows risk of taking alcohol with the female sexual dysfunction drug; Sprout will appeal agency's decision.