Search Orphan Drug Designations and Approvals
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Generic Name: | nilotinib | ||||||||||||||||
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Trade Name: | Tasigna | ||||||||||||||||
Date Designated: | 04/27/2006 | ||||||||||||||||
Orphan Designation: | Treatment of chronic myelogenous leukemia | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Novartis Pharmaceuticals Corporation One Health Plaza East Hanover, New Jersey 07936 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: | nilotinib |
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Trade Name: | Tasigna | |
Marketing Approval Date: | 10/29/2007 | |
Approved Labeled Indication: | For the use for chronic phase (CP) and accelerated phase (AP) Philadelphia chromosome positive chronic myelogenous leukemia (CML) in adult patients resistant to or intolerant to prior therapy that included imatinib. | |
Exclusivity End Date: | 10/29/2014 | |
Exclusivity Protected Indication* : | ||
2 | Generic Name: | nilotinib |
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Trade Name: | Tasigna | |
Marketing Approval Date: | 03/22/2018 | |
Approved Labeled Indication: | TASIGNA® (nilotinib) is indicated for the treatment of pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase and pediatric patients greater than or equal to 1 year of age with chronic phase Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) with resistance or intolerance to prior tyrosine-kinase inhibitor (TKI) therapy. | |
Exclusivity End Date: | 03/22/2025 | |
Exclusivity Protected Indication* : | TASIGNA® (nilotinib) is indicated for the treatment of pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase and pediatric patients greater than or equal to 1 year of age with chronic phase Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) with resistance or intolerance to prior tyrosine-kinase inhibitor (TKI) therapy. | |
3 | Generic Name: | nilotinib |
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Trade Name: | Tasigna | |
Marketing Approval Date: | 09/23/2021 | |
Approved Labeled Indication: | Treatment of pediatric patients greater than or equal to 1 year of age with chronic phase and accelerated phase Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) with resistance or intolerance to prior tyrosine-kinase inhibitor (TKI) therapy | |
Exclusivity End Date: | 09/23/2028 | |
Exclusivity Protected Indication* : | Treatment of pediatric patients greater than or equal to 1 year of age with accelerated phase Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) with resistance or intolerance to prior tyrosine-kinase inhibitor (TKI) therapy | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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