Ferric citrate Approval History

  • FDA approved: Yes (First approved September 5th, 2014)
  • Generic name: ferric citrate
  • Previous name: Zerenex
  • Company: Keryx Biopharmaceuticals, Inc.
  • Treatment for: Hyperphosphatemia of Renal Failure

Ferric Citrate is a phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.

FDA Approval History for ferric citrate

DateArticle
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

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