Skip to Content

Auryxia Approval History

Auryxia (ferric citrate) is a phosphate binder indicated for the control of serum phosphorus levels in dialysis patients; and an iron replacement product for the treatment of iron deficiency anemia in adult patients with chronic kidney disease who are not on dialysis.

Development History and FDA Approval Process for Auryxia

Nov  7, 2017Approval FDA Approves Auryxia (ferric citrate) Tablets as a Treatment for People with Iron Deficiency Anemia and Chronic Kidney Disease, Not on Dialysis
Nov 17, 2014Approval Keryx Biopharmaceuticals Announces Trade Name Auryxia for Ferric Citrate
Sep  8, 2014Approval Keryx Biopharmaceuticals Receives FDA Approval of Ferric Citrate for Dialysis Patients With Hyperphosphatemia
May 22, 2014Keryx Receives Notification of PDUFA Date Extension for Zerenex
Oct  8, 2013Keryx Biopharmaceuticals Announces FDA Acceptance for Filing of Zerenex New Drug Application
Aug  8, 2013Keryx Biopharmaceuticals Announces New Drug Application Submission for Zerenex for the Treatment of Hyperphosphatemia in Chronic Kidney Disease Patients on Dialysis

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.