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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: elranatamab-bcmm
Trade Name: Elrexfio
Date Designated: 10/12/2021
Orphan Designation: Treatment of multiple myeloma
Orphan Designation Status: Designated/Approved
Pfizer Inc.
66 Hudson Boulevard East
New York, New York 10001
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: elranatamab-bcmm
Trade Name: Elrexfio
Marketing Approval Date: 08/14/2023
Approved Labeled Indication: treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody
Exclusivity End Date: 08/14/2030 
Exclusivity Protected Indication* :  treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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