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.
More from Drug Safety
More from Pink Sheet
• By
Some employees were not impressed with FDA Commissioner Martin Makary's first speech to the agency staff, saying he did not seem to understand the agency's mission.
• By
The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.
• By
In a historic move for Africa, five products have been backed for approval via a pilot that tested a continental listing process.