Sprout’s Addyi Loses Blanket Alcohol Contraindication And REMS Distribution Restrictions

US FDA’s approval of labeling supplements for the hypoactive sexual desire disorder drug followed Sprout’s appeal of a safety-related change order; boxed warning now states patients should wait at least two hours after drinking alcohol before taking flibanserin.

Woman refuses to drink a alcohol. Female alcoholism concept. Treatment of alcohol addiction. Quit booze and alcoholism. - Image
Revised labeling warns women not to drink within two hours of taking Addyi. • Source: Shutterstock

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