Treats women less than 65 years of age with acquired, generalized hypoactive sexual…. NDA 22526, held by Sprout Pharms. Flibanserin.
As of Nov 14, 2026, NDA 22526 (Addyi), held by Sprout Pharms, was first approved by FDA on Aug 18, 2015, with 9 approved supplements and 0 published complete response letters.
ADDYI is indicated for the treatment of women less than 65 years of age with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to:
| Dec 13, 2025 | Supplement 13Efficacy (new indication or use) · Priority review | Approved | |
| Aug 18, 2015 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Addyi100MG · tablet;oral | Flibanserin | RxReference drug |
| Dec 13, 2025 | Supplement 13Efficacy (new indication or use) · Priority review | Approved | |
| Jan 21, 2025 | Supplement 12REMS | Approved | |
| Sep 29, 2021 | Supplement 10Labeling · Standard review | Approved | |
| Oct 9, 2019 | Supplement 9REMS | Approved | |
| Oct 9, 2019 | Supplement 8Labeling · Standard review | Approved | |
| Apr 11, 2019 | Supplement 6 | Approved | |
| Apr 2, 2019 | Supplement 7REMS | Approved | |
| Jun 16, 2017 | Supplement 4REMS | Approved | |
| Apr 8, 2016 | Supplement 2REMS | Approved | |
| Aug 18, 2015 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
