… FDA and European Medicines Agency authorization for a confirmatory phase 3 trial … , 2025, Sprout Pharmaceuticals announced FDA priority review of … an expanded indication of flibanserin (Addyi) to … trials are supporting expanded use of the non-hormonal treatment …

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… use of the non-hormonal medication in women who have gone … ) trials. Prior Approval of Flibanserin Flibanserin was FDA approved in 2015 for the treatment of … ;drugsatfda_docs/label/2015/022526lbl.pdf 3. Sprout Pharmaceuticals …

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… finished pharmaceuticals; according to FDA, these products include over-the-counter drug products … flibanserin, marketed as Addyi, within the meaning of the federal Food, Drug … sex pill for women”; while it has been indicated for treatment of …

… Chief Executive Officer Sprout Pharmaceuticals, Inc. 4350 … Drug Promotion (OPDP) United States RE: NDA 022526 ADDYI (flibanserin … Pill for Women…” (screenshot) “Addyi is the first FDA-approved treatment … of a medication or other drug substance. Additionally …

… Drug Administration (“FDA”) Office of Prescription Drug … ADDYI® (flibanserin) (“Addyi”). According to FDA, … pharmaceutical industry. Promotional Content  Addyi is the first FDA-approved medication … pill for women” and “Addyi is the first FDA-approved treatment …

… medicine, reproductive endocrinology, gynecologic oncology, and more. From FDA … by 3 phase 3 trials (OASIS 1, 2, … offer a novel nonhormonal treatment option for moderate … FDA granted Priority Review to Sprout Pharmaceuticals’ application to expand flibanserin …