• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

  • Print
  • Share
  • E-mail
-
 
Generic Name:  gilteritinib
Trade Name:  XOSPATA
Date Designated:  07/13/2017
Orphan Designation:  Treatment of acute myeloid leukemia (AML)
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  11/28/2018 
Approved Labeled Indication:  XOSPATA is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test.
Exclusivity End Date:    11/28/2025 
Exclusivity Protected Indication* :  XOSPATA is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test.
Astellas Pharma US, Inc.
1 Astellas Way
Northbrook, Illinois 60062
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
-
-