US FDA Squashes Sprout's Attempt To Remove Boxed Warning From Addyi Label
In sharp disagreement, FDA says postmarketing trial shows risk of taking alcohol with the female sexual dysfunction drug; Sprout will appeal agency's decision.
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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.
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.
AMAG Pharmaceutical’s HSDD drug Vyleesi, has been approved by the FDA. But analysts warn it must build the market in women who may not be aware they have a condition if it is to fare better than Sprout’s Addyi.