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In Recommending Flibanserin Approval, FDA Panelists Urge Alcohol Contraindication

 
• By Brenda Sandburg

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.

While an FDA panel recommended approval of Sprout Pharmaceuticals Inc.’s female sexual dysfunction drug Addyi (flibanserin), several members conditioned their vote on a labeling contraindication and a Risk Evaluation and Mitigation Strategy, despite uncertainties that either would be able to prevent the alcohol use that exacerbates adverse events.

At a joint June 4 meeting, FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 18-6 in favor of approval of flibanserin...

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EU CHMP Opinions And MAA Updates

 
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