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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: ((1r, 4r)-N1-(2-benzyl-7-(2-methyl-2H-tetrazol-5-yl)-9H-pyrimido[4,5-b]indol-4-yl)cyclohexane-1,4-diamine dihydrobromide dihydrate)-Expanded cord blood
Date Designated: 12/13/2018
Orphan Designation: Prevention of Graft-versus-Host-Disease
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
ExCellThera Inc.
2950 chemin de Polythechnique
Montreal
Canada

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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