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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: allogeneic processed thymus tissue-agdc
Trade Name: Rethymic
Date Designated: 08/15/2003
Orphan Designation: Treatment of congenital athymia
Orphan Designation Status: Designated/Approved
Enzyvant Therapeutics GmbH
Viaduktstrasse 8
CH-4051
Basel
Switzerland

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

Marketing approved:

1 Generic Name: allogeneic processed thymus tissue-agdc
Trade Name: Rethymic
Marketing Approval Date: 10/08/2021
Approved Labeled Indication: immune reconstitution in pediatric patients with congenital athymia
Exclusivity End Date: 10/08/2028 
Exclusivity Protected Indication* :  immune reconstitution in pediatric patients with congenital athymia
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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