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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: tisagenlecleucel
Trade Name: Kymriah
Date Designated: 09/16/2020
Orphan Designation: Treatment of follicular lymphoma
Orphan Designation Status: Designated/Approved
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.

Marketing approved:

1 Generic Name: tisagenlecleucel
Trade Name: Kymriah
Marketing Approval Date: 05/27/2022
Approved Labeled Indication: Treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy
Exclusivity End Date: 05/27/2029 
Exclusivity Protected Indication* :  Treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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