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US FDA Squashes Sprout's Attempt To Remove Boxed Warning From Addyi Label

 
• By Brenda Sandburg

In sharp disagreement, FDA says postmarketing trial shows risk of taking alcohol with the female sexual dysfunction drug; Sprout will appeal agency's decision.

Female Viagra

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.

FDA said it was ordering Sprout to revise the label "because the agency was not able to reach an agreement...

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