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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Nonfucosylated humanized immunoglobulin G1 (IgG1) monoclonal antibody targeting B-cell maturation antigen (SEA-BCMA)
Date Designated: 12/16/2021
Orphan Designation: Treatment of Multiple Myeloma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Seagen Inc.
21823 30th Drive SE
Bothell, Washington 98021
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.