Search Orphan Drug Designations and Approvals
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Generic Name: | Allogeneic gene-edited CD19-directed CAR T cells/azercabtagene zapreleucel |
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Date Designated: | 05/13/2020 |
Orphan Designation: | Treatment of mantle cell lymphoma |
Orphan Designation Status: | Designated |
FDA Orphan Approval Status: | Not FDA Approved for Orphan Indication |
Sponsor: |
Imugene Limited Suite 12.01, Level 12 Blight House, 4-6 Bligh Street, Gadigal Country Sydney, NSW 2000 Australia The sponsor address listed is the last reported by the sponsor to OOPD. |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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