Treats women less than 65 years of age with acquired, generalized hypoactive sexual…. Sold as Addyi. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 1 application for Flibanserin (sold as Addyi), first approved Aug 18, 2015, with 1 new use approved and 0 published complete response letters.
| Study | Phase | Status | Posted |
|---|---|---|---|
| A Study of Flibanserin in Breast Cancer Survivors on Tamoxifen or Aromatase InhibitorsBreast Cancer, Hyposexual Desire Disorder · Memorial Sloan Kettering Cancer Center | Phase 2 | Active, not recruiting | Oct 16, 2018 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Aug 18, 2015 | AddyiNDA 22526 · New molecular entity | Sprout Pharms | 9 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
