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Vyxeos FDA Approval History

Last updated by Judith Stewart, BPharm on March 31, 2021.

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 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.

Development Timeline for Vyxeos

DateArticle
Mar 30, 2021Approval  Jazz Pharmaceuticals Announces FDA Approval of Additional Indication for Vyxeos (daunorubicin and cytarabine) for the Treatment of Secondary Acute Myeloid Leukemia in Pediatric Patients
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

Further information

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