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# Regulatory Review Determination for Truseltiq
- URL: https://www.fdaweb.com/regulatory-review-determination-for-truseltiq/
- Published: 2023-12-07T12:00:00.000Z
- Updated: 2026-09-14T14:17:59.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155947

*Federal Register* notice: FDA has determined for patent term extension purposes the regulatory review period for QED Therapeutics’ Truseltiq (infigratinib), indicated for treating adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement as detected by an FDA-approved test. The regulatory review period is 4,258 days, of which 4,016 days occurred during the testing phase and 242 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-12-07/pdf/2023-26885.pdf?ref=fdaweb.com).