Search Orphan Drug Designations and Approvals

Marketing approved:
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
Sponsor:	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.

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 Jan. 1, 2013, to the present.