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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
QED Therapeutics, Inc.
8000 Marina Boulevard
Suite 400
Brisbane, California 94005
United States

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

Marketing approved:

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.
Exclusivity End Date: 05/28/2028 
Exclusivity Protected 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.

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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