FDA Reviewers Disagreed About Approval Of Sprout's Addyi

Post-approval trials could lead to future regulatory action on the female sexual dysfunction drug, FDA staff say in NEJM editorial detailing the product's review.

Some FDA reviewers opposed the approval of Sprout Pharmaceuticals Inc.’s female sexual dysfunction drug Addyi (flibanserin), the agency notes in an editorial in the New England Journal of Medicine.

The perspective piece was penned by 11 staffers, led by Hylton Joffe, director of FDA’s Division of Bone, Reproductive and...

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