Prescription medicine
Cytarabine and daunorubicin Brand names: Vyxeos
Cytarabine and daunorubicin (Vyxeos) is a prescription medicine with an FDA approval on record since 2017. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the cytarabine and daunorubicin FDA label on DailyMed (effective January 30, 2026, Jazz Pharmaceuticals, Inc.); the NDA 209401 record on Drugs@FDA; every cytarabine and daunorubicin label on DailyMed.
Highlights of the record
FDA label of January 30, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
DO NOT INTERCHANGE WITH OTHER DAUNORUBICIN AND/OR CYTARABINE-CONTAINING PRODUCTS •.
VYXEOS has different dosage recommendations than daunorubicin hydrochloride injection, cytarabine injection, daunorubicin citrate liposome injection, and cytarabine liposome injection. Verify drug name and dose prior to preparation and administration to avoid dosing errors [see Warnings and Precautions ( 5.1 )]. WARNING: DO NOT INTERCHANGE WITH OTHER DAUNORUBICIN AND/OR CYTARABINE-CONTAINING PRODUCTS See full prescribing information for complete boxed warning.
VYXEOS has different dosage recommendations than daunorubicin hydrochloride injection, cytarabine injection, daunorubicin citrate liposome injection, and cytarabine liposome injection. Verify drug name and dose prior to preparation and administration to avoid dosing errors ( 5.1 ).
Used for
From the label: indications and usageVYXEOS 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.
Forms and strengths
- 100 mg/20ml / 44 mg/20ml
Injection (powder) (lyophilized) for suspension.
On the market
- Earliest approval on file
- August 3, 2017 Vyxeos, Jazz Pharms Therap; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- April 15, 2033 Vyxeos injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,336 through July 30, 2026
What is cytarabine and daunorubicin used for?
From the label: indications and usageVYXEOS 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. VYXEOS is a liposomal combination of daunorubicin, an anthracycline topoisomerase inhibitor, and cytarabine, a nucleoside metabolic inhibitor, that 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.
Conditions named in the indications of cytarabine and daunorubicin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Anthracycline Topoisomerase Inhibitor and Nucleoside Metabolic Inhibitor.
Source: FDA drug label (VYXEOS), Jazz Pharmaceuticals, Inc., effective January 30, 2026 (SPL set 7ea701ce-e7d3-4349-a9c2-642a501d45c8), via openFDA; the full label on DailyMed
Is there a generic for cytarabine and daunorubicin (Vyxeos)?
No generic cytarabine and daunorubicin is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 8 patents for Vyxeos injection, the last expiring on April 15, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2017 earliest approval on file
- 2033 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for cytarabine and daunorubicin?
The FDA Adverse Event Reporting System holds 2,336 reports that list cytarabine and daunorubicin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 771 are coded as a death and 560 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as cytarabine and daunorubicin?
34 other medicines are given the same way (intravenous) and in the same FDA class as cytarabine and daunorubicin or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Doxorubicin | Leukemia, lymphoma and myeloma | 16 labelers | n/a | No current entry |
| Nelarabine | Leukemia, lymphoma and myeloma | 12 labelers | n/a | No current entry |
| Idarubicin | Leukemia, lymphoma and myeloma | 2 labelers | n/a | No current entry |
| Clofarabine | Leukemia, lymphoma and myeloma | 9 labelers | n/a | No current entry |
| Fludarabine | Leukemia, lymphoma and myeloma | 6 labelers | n/a | No current entry |
| Pentostatin | Leukemia, lymphoma and myeloma | none listed | n/a | In shortage |
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 15 labelers | n/a | No current entry |
| Bortezomib | Leukemia, lymphoma and myeloma | 22 labelers | n/a | No current entry |
Every medicine labeled for the same conditions as cytarabine and daunorubicin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to cytarabine and daunorubicin
- 34 medicines for the same use
- Other anthracycline topoisomerase inhibitors
- the pharmacologic class, with prices and generics
- Cytarabine and daunorubicin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other