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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: brexucabtagene autoleucel
Date Designated: 04/20/2016
Orphan Designation: Treatment of chronic lymphocytic leukemia.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 01/21/2022
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Kite Pharma, Inc.
2225 Colorado Avenue
Santa Monica, California 90404
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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