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 Urologic Products. They give a detailed account of the review and approval of Addyi, noting safety and efficacy concerns about the drug and how they are being handled
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