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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: futibatinib
Trade Name: Lytgobi
Date Designated: 05/23/2018
Orphan Designation: Treatment of cholangiocarcinoma (CCA)
Orphan Designation Status: Designated/Approved
Taiho Oncology, Inc.
101 Carnegie Center, Suite 101
Princeton, New Jersey 08540
United States

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

Marketing approved:

1 Generic Name: futibatinib
Trade Name: Lytgobi
Marketing Approval Date: 09/30/2022
Approved Labeled Indication: Treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements
Exclusivity End Date: 09/30/2029 
Exclusivity Protected Indication* :  Treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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