Treats premenopausal women with acquired, generalized hypoactive … desire disorder (HSDD). NDA 210557, held by Cosette. Bremelanotide Acetate.
As of Nov 14, 2026, NDA 210557 (Vyleesi (Autoinjector)), held by Cosette, was first approved by FDA on Jun 21, 2019, with 2 approved supplements and 0 published complete response letters.
VYLEESI is indicated for the treatment of premenopausal women 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: A co-existing medical or psychiatric condition, Problems with the relationship, or The effects of a medication or drug substance. Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation or partner. Limitations of Use VYLEESI is not indicated for the treatment of HSDD in postmenopausal women or in men.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 21, 2019 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vyleesi (Autoinjector)EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) · solution;subcutaneous | Bremelanotide Acetate | RxReference drug |
| Oct 22, 2026 | Supplement 5Labeling · Standard review | Approved | |
| Oct 23, 2020 | Supplement 2Labeling · Standard review | Approved | |
| Jun 21, 2019 | 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
