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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Humanized IgG-1 antibody targeting human transferrin receptor conjugated to human iduronate-2-sulfatase
Date Designated: 10/15/2018
Orphan Designation: Treatment of Mucopolysaccharidosis Type II (MPS II) or Hunter Syndrome
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
JCR Pharmaceuticals Co., Ltd.
2-4 Kasuga-cho
Ashiya, Hyogo Prefecture
Japan

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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