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Auryxia Approval History

FDA Approved: Yes (First approved September 5, 2014)
Brand name: Auryxia
Generic name: ferric citrate
Dosage form: Tablets
Company: Keryx Biopharmaceuticals, Inc.
Treatment for: Hyperphosphatemia of Renal Failure, Anemia Associated with Chronic Renal Failure

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

DateArticle
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

Further information

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