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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 anti-CD19, Fc engineered, monoclonal antibody with enhanced binding to FcyRIIb
Date Designated: 05/09/2017
Orphan Designation: Treatment of immunoglobulin G4-related disease
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Zenas BioPharma (USA) LLC.
1000 Winter Street
North Building, Suite 1200
Waltham, Massachusetts 02451
United States

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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