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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Arsenic trioxide
Trade Name: Trisenox
Date Designated: 03/03/1998
Orphan Designation: Treatment of acute promyelocytic leukemia.
Orphan Designation Status: Designated/Approved
Teva Branded Pharmaceutical Products R&D, Inc.
41 Moores Road
Frazer, Pennsylvania 19355
United States

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

Marketing approved:

1 Generic Name: Arsenic trioxide
Trade Name: Trisenox
Marketing Approval Date: 09/25/2000
Approved Labeled Indication: For induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation of PML/RAR-alpha gene expression.
Exclusivity End Date: 09/25/2007 
Exclusivity Protected Indication* :  
2 Generic Name: Arsenic trioxide
Trade Name: Trisenox
Marketing Approval Date: 01/12/2018
Approved Labeled Indication: In combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
Exclusivity End Date: 01/12/2025 
Exclusivity Protected Indication* :  In combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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