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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 B-cell maturation antigen (BCMA)-directed, genetically engineered T cell immunotherapy product derived from an autologous leukapheresis
Date Designated: 02/21/2023
Orphan Designation: Treatment of multiple myeloma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, New Jersey 07936
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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