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# Approval Withdrawn for TG Therapeutics’ Ukoniq
- URL: https://www.fdaweb.com/approval-withdrawn-for-tg-therapeutics-ukoniq/
- Published: 2022-05-31T12:00:00.000Z
- Updated: 2026-09-14T17:46:43.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151926

*Federal Register* notice: FDA is withdrawing approval of TG Therapeutics’ NDA for Ukoniq (umbralisib tosylate) tablets based on a company request. The drug gained accelerated approval 2/2021 for treating certain adult patients with relapsed or refractory marginal zone lymphoma and relapsed or refractory follicular lymphoma. Earlier this year, FDA issued a warning about a possible increased risk of death with Ukoniq and an advisory committee was planned in April to discuss the issue, but the company requested its withdrawal and waived its opportunity for a hearing. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-05-31/pdf/2022-11631.pdf?ref=fdaweb.com).