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# Jazz Begins Rolling NDA for Leukemia Drug Vyxeos
- URL: https://www.fdaweb.com/jazz-begins-rolling-nda-for-leukemia-drug-vyxeos/
- Published: 2016-10-03T12:00:00.000Z
- Updated: 2026-09-14T21:36:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136963

Jazz Pharmaceuticals has begun a rolling NDA submission for Vyxeos (cytarabine and daunorubicin liposome injection), an investigational agent for treating acute myeloid leukemia (AML). The company expects to complete the submission of the NDA by early next year, and will request a priority review. Vyxeos was granted breakthrough therapy designation in May for the treating adults with therapy-related AML or AML with myelodysplasia-related changes. The drug was advanced and studied by Celator Pharmaceuticals, which Jazz acquired in July.

Vyxeo or CPX-351, is a combination of cytarabine and daunorubicin encapsulated within a nano-scale liposome at a 5:1 molar ratio, according to Jazz. The drug was advanced and studied by Celator Pharmaceuticals, which Jazz acquired in July.