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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: nilotinib
Trade Name: Tasigna
Date Designated: 04/27/2006
Orphan Designation: Treatment of chronic myelogenous leukemia
Orphan Designation Status: Designated/Approved
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.

Marketing approved:

1 Generic Name: nilotinib
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
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
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

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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