(daunorubicin and cytarabine) liposome

FDA Drug Profile — VYXEOS

(daunorubicin and cytarabine) liposome is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including VYXEOS. Available dosage form: injection, powder, lyophilized, for suspension.

Drug Details

Generic Name
(daunorubicin and cytarabine) liposome
Brand Names
VYXEOS
Application Number
NDA209401
Sponsor
Jazz Pharmaceuticals, Inc.
NDC Codes
1
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Routes
INTRAVENOUS
Active Ingredients
CYTARABINE, DAUNORUBICIN

Indications and Usage

1 INDICATIONS AND USAGE 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. 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. ( 1 )