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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  Cytarabine:daunorubicin liposome injection
Trade Name:  VYXEOS
Date Designated:  08/22/2008
Orphan Designation:  Treatment of acute myeloid leukemia
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  08/03/2017 
Approved Labeled Indication:  Treatment of adults with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC)
Exclusivity End Date:    08/03/2024 
Exclusivity Protected Indication* :  Treatment of adults with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC)
Celator Pharmaceuticals, Inc.
200 Princeton South Corporate Center
Suite 180
Ewing, New Jersey 08628
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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