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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: donislecel-jujn
Trade Name: Lantidra
Date Designated: 02/01/2017
Orphan Designation: Treatment of Brittle Type 1 Diabetes
Orphan Designation Status: Designated/Approved
CellTrans Inc.
2201 W. Campbell Park Drive
Chicago, Illinois 60612
United States

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

Marketing approved:

1 Generic Name: donislecel-jujn
Trade Name: Lantidra
Marketing Approval Date: 06/28/2023
Approved Labeled Indication: treatment of adults with Type 1 diabetes who are unable to approach target HbA1c because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education (exclusivity waived)
Exclusivity End Date: N/A  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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