The US FDA revealed its clash with Sprout Pharmaceuticals Inc. over the company's push to drop a boxed warning in labeling for its female sexual dysfunction drug Addyi (flibanserin) in announcing a safety labeling change.
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.
