Search Orphan Drug Designations and Approvals
-
Generic Name: | infigratinib | ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Trade Name: | Truseltiq | ||||||||||||||||
Date Designated: | 09/11/2019 | ||||||||||||||||
Orphan Designation: | Treatment of cholangiocarcinoma | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
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. | |
-