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.

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Drug Safety

More from Pink Sheet