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Feraheme Approval History

  • FDA approved: Yes (First approved June 30th, 2009)
  • Brand name: Feraheme
  • Generic name: ferumoxytol
  • Dosage form: Intravenous Injection
  • Company: AMAG Pharmaceuticals, Inc.
  • Treatment for: Anemia Associated with Chronic Renal Failure

Feraheme (ferumoxytol) is an iron replacement therapy for the treatment of iron deficiency anemia in adult patients with chronic kidney disease.

Development History and FDA Approval Process for Feraheme

DateArticle
Jun 30, 2009Approval FDA Approves Feraheme to Treat Iron Deficiency Anemia in Adult Chronic Kidney Disease Patients
May 12, 2009AMAG Pharmaceuticals Announces New PDUFA Date for Feraheme (ferumoxytol injection)
Dec 23, 2008AMAG Pharmaceuticals Receives Complete Response Letter from the FDA for Ferumoxytol
Nov 13, 2008AMAG Pharmaceuticals Announces Ferumoxytol Resubmission Designated Complete, Class 1 Response by the FDA
Oct 20, 2008AMAG Pharmaceuticals Receives Complete Response Letter from FDA for Ferumoxytol
Feb 19, 2008AMAG Pharmaceuticals, Inc. Announces FDA Acceptance for Filing of Ferumoxytol New Drug Application in Chronic Kidney Disease
Dec 19, 2007AMAG Pharmaceuticals, Inc. Submits New Drug Application to FDA for Ferumoxytol in Chronic Kidney Disease Patients

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