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.
You may also be interested in...
Agency directs Sprout to disseminate corrective messages about the risks associated with the female sexual dysfunction pill. Sprout previously challenged FDA’s alcohol labeling requirements.
The view from 2020: Scrip looks back over the last decade at the drug launches that defied expectations – for the worse.
In sharp disagreement, FDA says postmarketing trial shows risk of taking alcohol with the female sexual dysfunction drug; Sprout will appeal agency's decision.