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Jesduvroq FDA Approval History

Last updated by Judith Stewart, BPharm on Feb 22, 2023.

FDA Approved: Yes (First approved February 1, 2023)
Brand name: Jesduvroq
Generic name: daprodustat
Dosage form: Tablets
Company: GlaxoSmithKline
Treatment for: Anemia Due to Chronic Kidney Disease

Jesduvroq (daprodustat) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) for the treatment of patients with anemia of chronic kidney disease (CKD).

Development timeline for Jesduvroq

Feb  1, 2023Approval FDA Approves Jesduvroq (daprodustat) for Anemia Caused by Chronic Kidney Disease for Adults on Dialysis
Oct 27, 2022GSK Reports Outcome from US FDA Advisory Committee Meeting on Daprodustat for Anemia of CKD
Apr 19, 2022US Food and Drug Administration Accepts New Drug Application for Daprodustat
Nov  5, 2021GSK Announces Positive Phase III Efficacy and Safety Data for Daprodustat in Patients with Anemia Due to Chronic Kidney Disease
Jul 16, 2021GSK Announces Positive Headline Results from Five Phase 3 Studies of Daprodustat for Patients with Anemia due to Chronic Kidney Disease

Further information

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