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Search Orphan Drug Designations and Approvals

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Marketing approved:
Generic Name:	isavuconazonium sulfate
Trade Name:	Cresemba
Date Designated:	05/06/2013
Orphan Designation:	Treatment of invasive aspergillosis
Orphan Designation Status:	Designated/Approved
Sponsor:	Astellas Pharma Global Development Inc. 1 Astellas Way Northbrook, Illinois 60062 United States The sponsor address listed is the last reported by the sponsor to OOPD.

1	Generic Name:	isavuconazonium sulfate
	Trade Name:	Cresemba
	Marketing Approval Date:	03/06/2015
	Approved Labeled Indication:	Treatment of invasive aspergillosis in patients 18 years of age and older
	Exclusivity End Date:	03/06/2022
	Exclusivity Protected Indication* :	Treatment of invasive aspergillosis in patients 18 years of age and older

2	Generic Name:	isavuconazonium sulfate
	Trade Name:	Cresemba
	Marketing Approval Date:	12/08/2023
	Approved Labeled Indication:	treatment of invasive aspergillosis in adults and pediatric patients 1 year of age and older
	Exclusivity End Date:	12/08/2030
	Exclusivity Protected Indication* :	treatment of invasive aspergillosis in pediatric patients 1 year of age and older

3	Generic Name:	isavuconazonium sulfate
	Trade Name:	Cresemba
	Marketing Approval Date:	12/08/2023
	Approved Labeled Indication:	treatment of invasive aspergillosis in adults and pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater
	Exclusivity End Date:	12/08/2030
	Exclusivity Protected Indication* :	treatment of invasive aspergillosis in pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.

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