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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: teclistamab-cqyv
Trade Name: Tecvayli
Date Designated: 11/24/2020
Orphan Designation: Treatment of multiple myeloma
Orphan Designation Status: Designated/Approved
Janssen Biotech, Inc.
920 Route 202
Raritan, New Jersey 08869
United States

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

Marketing approved:

1 Generic Name: teclistamab-cqyv
Trade Name: Tecvayli
Marketing Approval Date: 10/25/2022
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: 10/25/2029 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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