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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 with the company, which was continuing to request removal of the boxed warning and

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