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