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# FDA Approves New Vyxeos Indication
- URL: https://www.fdaweb.com/fda-approves-new-vyxeos-indication/
- Published: 2021-03-31T12:00:00.000Z
- Updated: 2026-09-14T16:52:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149011

FDA has approved a new indication for Jazz Pharmaceuticals’ Vyxeos (daunorubicin and cytarabine) to treat newly-diagnosed therapy-related acute myeloid leukemia with myelodysplasia-related changes in pediatric patients aged one year and older. A company [statement](https://www.marketwatch.com/press-release/jazz-pharmaceuticals-announces-fda-approval-of-additional-indication-for-vyxeos-daunorubicin-and-cytarabine-for-the-treatment-of-secondary-acute-myeloid-leukemia-in-pediatric-patients-2021-03-30?tesla=y&ref=fdaweb.com) says approval of the new indication was supported by safety data from two trials.

Vyxeos has a Boxed Warning as it cannot be substituted with other daunorubicin and/or cytarabine-containing products, Jazz says.

Vyxeos is described as a liposomal combination of daunorubicin, an anthracycline topoisomerase inhibitor, and cytarabine, a nucleoside metabolic inhibitor, that is now indicated for treating newly-diagnosed therapy-related acute myeloid leukemia with myelodysplasia-related changes in adults and pediatric patients one year old and older.