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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: isavuconazonium sulfate
Trade Name: Cresemba
Date Designated: 10/25/2013
Orphan Designation: Treatment of zygomycosis
Orphan Designation Status: Designated/Approved
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.

Marketing approved:

1 Generic Name: isavuconazonium sulfate
Trade Name: Cresemba
Marketing Approval Date: 03/06/2015
Approved Labeled Indication: Treatment of invasive mucormycosis in patients 18 years of age and older
Exclusivity End Date: 03/06/2022 
Exclusivity Protected Indication* :  Treatment of invasive mucormycosis 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 mucormycosis in adults and pediatric patients 6 years of age and older who weigh 16 kg and greater
Exclusivity End Date: 12/08/2030 
Exclusivity Protected Indication* :  treatment of invasive mucormycosis in pediatric patients 6 years of age and older who weigh 16 kg and greater
3 Generic Name: isavuconazonium sulfate
Trade Name: Cresemba
Marketing Approval Date: 12/08/2023
Approved Labeled Indication: treatment of invasive mucormycosis in adults and pediatric patients 1 year of age and older
Exclusivity End Date: 12/08/2030 
Exclusivity Protected Indication* :  treatment of invasive mucormycosis in pediatric patients 1 year of age 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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