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Vyxeos FDA 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 Timeline for Vyxeos

DateArticle
Aug  3, 2017ApprovalFDA 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

Further information

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