Search Orphan Drug Designations and Approvals
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Generic Name: | Arsenic trioxide | ||||||||||||||||
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Trade Name: | Trisenox | ||||||||||||||||
Date Designated: | 03/03/1998 | ||||||||||||||||
Orphan Designation: | Treatment of acute promyelocytic leukemia. | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | Arsenic trioxide |
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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 |
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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. | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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