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  • Regulatory NewsRegulatory News

    FDA Tells Company to Pull Press Release on Drinking With Female Libido Drug

    Last April, Sprout Pharmaceuticals completed postmarketing trials for its drug Addyi (flibanserin), which is used to treat decreased sexual desire in women, and the US Food and Drug Administration (FDA) said it could change the labeling of the drug to clarify that although a boxed warning is still necessary, alcohol does not have to be avoided completely. FDA’s decision on the label followed a push from Sprout to remove the warning entirely. Sprout touted newly released...
  • Regulatory NewsRegulatory News

    FDA Softens Stance on Drinking Alcohol With Female Libido Drug

    Following the completion of postmarketing studies for Sprout Pharmaceuticals’ Addyi (flibanserin), which is used to treat decreased sexual desire in women, the US Food and Drug Administration (FDA) has changed the labeling for the drug to clarify that although a boxed warning is still necessary, alcohol does not have to be avoided completely. Specifically, the agency told women to discontinue drinking alcohol at least two hours before taking Addyi at bedtime or to skip ...