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

 
• By Sue Sutter

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

Sprout Pharmaceuticals Inc.’s Addyi (flibanserin) has shed its labeled alcohol contraindication and restricted distribution requirements, but not without more tension between the company and the US Food and Drug Administration.

On 9 October, the agency approved two labeling supplements for the hypoactive

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