Search Orphan Drug Designations and Approvals
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Generic Name: | infigratinib | |
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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Orphan Designation Status: | Designated/Approved/Designation Withdrawn or Revoked | |
Date Designation Withdrawn or Revoked: | 08/04/2023 | |
Sponsor: |
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 |
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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 (Indication withdrawn 5/16/2024) | |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 | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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