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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: dasatinib
Trade Name: Phyrago
Date Designated: 10/05/2021
Orphan Designation: Treatment of chronic myelogenous leukemia
Orphan Designation Status: Designated/Approved
Nanocopoeia, LLC
639 Campus Drive
New Brighton, Minnesota 55112
United States

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

Marketing approved:

1 Generic Name: dasatinib
Trade Name: Phyrago
Marketing Approval Date: 12/05/2023
Approved Labeled Indication: treatment of adult patients with: newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase; or chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib
Exclusivity End Date: TBD  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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