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Vyxeos Approval History

FDA Approved: Yes (First approved August 3, 2017)
Brand name: Vyxeos
Generic name: cytarabine and daunorubicin
Dosage form: Injection
Company: Jazz Pharmaceuticals plc
Treatment for: Acute Myeloid Leukemia

Vyxeos (cytarabine and daunorubicin liposome injection) is a liposomal combination of cytarabine, a nucleoside metabolic inhibitor, and daunorubicin, an anthracycline topoisomerase inhibitor, indicated for the treatment of adults with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

Development History and FDA Approval Process for Vyxeos

Aug  3, 2017Approval FDA Approves Vyxeos (daunorubicin and cytarabine) Liposome for Injection for Certain Types of Poor-Prognosis Acute Myeloid Leukemia
May 31, 2017Jazz Pharmaceuticals Announces FDA Acceptance of NDA for Vyxeos (CPX-351), an Investigational Treatment for Acute Myeloid Leukemia, with Priority Review Status
Apr  3, 2017Jazz Pharmaceuticals Completes Rolling Submission of New Drug Application for Vyxeos (CPX-351), an Investigational Treatment for Acute Myeloid Leukemia
Oct  3, 2016Jazz Pharmaceuticals Initiates Rolling NDA Submission for Vyxeos (CPX-351) Expects to Complete NDA Submission by Early 2017
May 19, 2016Celator Pharmaceuticals Announces Vyxeos Granted Breakthrough Therapy Designation
Mar 14, 2016Celator Announces Phase 3 Trial for Vyxeos™ (CPX-351) in Patients with High-Risk Acute Myeloid Leukemia Demonstrates Statistically Significant Improvement in Overall Survival
Dec 11, 2012Celator Pharmaceuticals Announces Data on the Effects of CPX-351 in High Risk AML Presented at the ASH Annual Meeting
Jun  5, 2012Celator Pharmaceuticals Announces Presentations of Positive Survival Analyses from CPX-351 Studies at ASCO Annual Meeting
Dec 12, 2011Celator Pharmaceuticals and the Leukemia & Lymphoma Society Announce Positive Data from Phase 2b Study of CPX-351 at the American Society of Hematology Annual Meeting
Dec  7, 2010Celator Pharmaceuticals Presents Positive Data from Phase 2 Study of CPX-351 at the American Society of Hematology Annual Meeting
Jun  7, 2010Celator Pharmaceuticals Announces Data on Remissions With CPX-351 Following Induction Failure
May  3, 2010Celator Pharmaceuticals Announces Positive Data From Phase 2 Study of CPX-351 in Acute Myeloid Leukemia

Further information

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