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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Thiotepa
Trade Name: Tepadina
Date Designated: 04/02/2007
Orphan Designation: Conditioning treatment prior to hematopoietic stem cell transplantation
Orphan Designation Status: Designated/Approved
ADIENNE S.A.
Via Zurigo, 46
Lugano
Switzerland

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

Marketing approved:

1 Generic Name: Thiotepa
Trade Name: Tepadina
Marketing Approval Date: 01/26/2017
Approved Labeled Indication: Indicated for reducing the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogenic hematopoietic progenitor (stem) cell transplantation for pediatric patients with class 3 beta-thalassemia
Exclusivity End Date: 01/26/2024 
Exclusivity Protected Indication* :  Indicated for reducing the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogenic hematopoietic progenitor (stem) cell transplantation for pediatric patients with class 3 beta-thalassemia
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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