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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: Danziten
Date Designated: 04/10/2025
Orphan Designation: Treatment of Chronic Myelogenous Leukemia
Orphan Designation Status: Designated/Approved
Azurity Pharmaceuticals, Inc.
8 Cabot Road
Suite 2000
Woburn, Massachusetts 01801
United States

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

Marketing approved:

1 Generic Name: nilotinib
Trade Name: Danziten
Marketing Approval Date: 11/07/2024
Approved Labeled Indication: treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase; and treatment of adult patients with chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) resistant or intolerant to prior therapy that included imatinib
Exclusivity End Date: N/A  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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