🏅 FDA Orphan Designation

VYXEOS

Cytarabine:daunorubicin liposome injection; daunorubicin and cytarabine (liposome); daunorubicin and cytarabine liposome for injection

Manufacturer: Celator Pharmaceuticals, Inc. (a Jazz Pharmaceuticals Company)

Indicated for:

Acute myeloid leukemiaOrphanAcute myeloid leukaemia with myelodysplasia-related features

FDA-Approved Indications (2)

Acute myeloid leukemiaOrphan Designation

treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients ages 1 year and older

Acute myeloid leukaemia with myelodysplasia-related features

treatment of newly-diagnosed AML with myelodysplasia-related changes (AML-MRC)

Population: adults and pediatric patients ages 1 year and older

Indications & Usage

treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients ages 1 year and older ||| Treatment of adults with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC)

Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.