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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: infigratinib
Trade Name: Truseltiq
Date Designated: 09/11/2019
Orphan Designation: Treatment of cholangiocarcinoma
Orphan Designation Status: Designated/Approved/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 08/04/2023
QED Therapeutics, Inc.
1800 Owens Street, 12 Floor
San Francisco, California 94148
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
1 Generic Name: infigratinib
Trade Name: Truseltiq
Marketing Approval Date: 05/28/2021
Approved Labeled Indication: Treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. (Indication withdrawn 5/16/2024)
Exclusivity End Date: 08/04/2023 

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.