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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: a humanized IgG4 monoclonal antibody, produced in CHO cells, that binds to and inhibits the activated form of the classical complement pathway (CP) specific serine protease, C1s
Date Designated: 01/12/2023
Orphan Designation: Treatment of Autoimmune Hemolytic Anemia (AIHA)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Bioverativ USA Inc
225 Second Avenue
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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