Treats moderate to severe vasomotor symptoms due to menopause. NDA 216578, held by Astellas. Fezolinetant.
As of Nov 14, 2026, NDA 216578 (Veozah), held by Astellas, was first approved by FDA on May 12, 2023, with 2 approved supplements and 0 published complete response letters.
VEOZAH is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 12, 2023 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Veozah45MG · tablet;oral | Fezolinetant | RxReference drug |
| Dec 16, 2024 | Supplement 4Labeling · Standard review | Approved | |
| Aug 31, 2024 | Supplement 3Labeling · Standard review | Approved | |
| May 12, 2023 | Original applicationNew molecular entity · Priority 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
