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Truseltiq FDA Approval History

Last updated by Judith Stewart, BPharm on May 21, 2024.

FDA Approved: Yes (Discontinued) (First approved May 28, 2021)
Brand name: Truseltiq
Generic name: infigratinib
Dosage form: Capsules
Company: BridgeBio Pharma, Inc.
Treatment for: Cholangiocarcinoma

Truseltiq (infigratinib) is an FGFR tyrosine kinase inhibitor indicated for the 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.

Development timeline for Truseltiq

May 16, 2024FDA Announces Final Withdrawal of the Approval of Truseltiq (infigratinib)
May 28, 2021Approval FDA Approves Truseltiq (infigratinib) for the Treatment of Cholangiocarcinoma
Dec  1, 2020BridgeBio Pharma And Affiliate QED Therapeutics Announce FDA Acceptance Of New Drug Application For Infigratinib For The Treatment Of Cholangiocarcinoma

Further information

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