Treats newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with…. NDA 209401, held by Jazz Pharms Therap. Cytarabine; Daunorubicin.
As of Nov 13, 2026, NDA 209401 (Vyxeos), held by Jazz Pharms Therap, was first approved by FDA on Aug 3, 2017, with 4 approved supplements and 0 published complete response letters.
VYXEOS is indicated for the treatment of newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.
| Jan 27, 2026 | Supplement 18Efficacy (new indication or use) · Priority review | Approved | |
| Sep 27, 2022 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Mar 30, 2021 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Aug 3, 2017 | Original applicationNew combination · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vyxeos100MG;44MG · powder;intravenous | Cytarabine; Daunorubicin | RxReference drug |
| Jan 27, 2026 | Supplement 18Efficacy (new indication or use) · Priority review | Approved | |
| Sep 27, 2022 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Mar 30, 2021 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Jan 13, 2020 | Supplement 2Labeling · Standard review | Approved | |
| Aug 3, 2017 | Original applicationNew combination · 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
