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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: autologous enriched T cells transduced with a lentiviral vector to express an anti-CD19 Chimeric Antigen Receptor
Date Designated: 11/04/2019
Orphan Designation: Treatment of acute lymphoblastic leukemia
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Autolus Incorporated, US subsidiary of Autolus Limited
805 King Farm Boulevard
Suite 550
Rockville, Maryland 20850
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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