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# Jesduvroq Not Withdrawn Over Safety/Efficacy
- URL: https://www.fdaweb.com/jesduvroq-not-withdrawn-over-safety-efficacy/
- Published: 2024-11-19T12:00:00.000Z
- Updated: 2026-09-14T14:47:27.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5158212

*Federal Register* notice: FDA has determined that GlaxoSmithKline’s Jesduvroq (daprodustat) tablets were not withdrawn due to safety or effectiveness reasons. This action will allow the agency to approve ANDAs that reference the product if all other legal and regulatory requirements are met. Jesduvroq is a hypoxia-inducible factor prolyl hydroxylase inhibitor indicated for treating anemia due to chronic kidney disease in adults who have been receiving dialysis for at least four months. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-11-19/pdf/2024-26915.pdf?ref=fdaweb.com).