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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; daunorubicin and cytarabine (liposome); daunorubicin and cytarabine liposome for injection
Trade Name: VYXEOS ; Vyxeos ; Vyxeos
Date Designated: 08/22/2008
Orphan Designation: Treatment of acute myeloid leukemia
Orphan Designation Status: Designated/Approved
Celator Pharmaceuticals, Inc. (a Jazz Pharmaceuticals Company)
3170 Porter Drive
Palo Alto, California 94304
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Cytarabine:daunorubicin liposome injection; daunorubicin and cytarabine (liposome); daunorubicin and cytarabine liposome for injection
Trade Name: VYXEOS ; Vyxeos ; Vyxeos
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)
2 Generic Name: Cytarabine:daunorubicin liposome injection; daunorubicin and cytarabine (liposome); daunorubicin and cytarabine liposome for injection
Trade Name: VYXEOS ; Vyxeos ; Vyxeos
Marketing Approval Date: 03/30/2021
Approved Labeled Indication: treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients ages 1 year and older
Exclusivity End Date: 03/30/2028 
Exclusivity Protected Indication* :  treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in pediatric patients ages 1 year and older
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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