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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: clazakizumab
Date Designated: 08/08/2019
Orphan Designation: Treatment of chronic antibody-mediated rejection in kidney transplant recipients
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
CSL Behring
1020 First Avenue
P.O. Box 61501
King of Prussia, Pennsylvania 19406
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.