FDA approves liposome-encapsulated combination of …
On August 3, 2017, the U.S. Food and Drug Administration granted regular approval to a liposome-encapsulated combination of daunorubicin and cytarabine (VYXEOS, Jazz …
label - Food and Drug Administration
VYXEOS is a liposomal combination of daunorubicin, an anthracycline topoisomerase inhibitor, and cytarabine, a nucleoside metabolic inhibitor, that is indicated for the treatment of adults with...
FDA approves first treatment for certain types of poor-prognosis …
The U.S. Food and Drug Administration today approved Vyxeos for the treatment of adults with two types of acute myeloid leukemia (AML): newly diagnosed therapy-related AML (t-AML) or …
Competitive Generic Therapy Approvals | FDA
Nov 14, 2025 · Explore the FDA’s Competitive Generic Therapy Approvals page, offering insights into the program designed to encourage generic drug competition. Access information about …
First Generic Drug Approvals | FDA
Oct 23, 2025 · To view all Generic Drug Approvals and Tentative Approvals, use the "Drug Approval Reports by Month" feature on Drugs@FDA and select "Original Abbreviated New …
VYXEOS Drug Patent Profile
Nov 24, 2025 · VYXEOS is protected by ten US patents and one FDA Regulatory Exclusivity. Based on analysis by DrugPatentWatch, the earliest date for a generic version of VYXEOS is …
Vyxeos FDA Approval History - Drugs.com
Mar 31, 2021 · FDA approval history for Vyxeos (cytarabine and daunorubicin) used to treat Acute Myeloid Leukemia. Supplied by Jazz Pharmaceuticals plc.
FDA Approval Summary: (Daunorubicin and Cytarabine) …
May 1, 2019 · There remains a clear need for new treatments for patients with AML in these poor-risk subgroups. Herein, we summarize the review for the FDA approval of Vyxeos (Jazz …
It is approved, effective on the date of this letter, for use as recommended in the enclosed agreed-upon labeling.
FDA Approves VYXEOS® - accp1.org
On August 3, 2017, the US Food & Drug Administration (FDA) approved VYXEOS (daunorubicin and cytarabine) liposome for injection for the treatment of adult patients with newly-diagnosed …