Skip to Content

Feraheme Approval History

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

Development History and FDA Approval Process for Feraheme

Feb  5, 2018Approval AMAG Pharmaceuticals Announces FDA Approval of Feraheme (ferumoxytol injection) for All Eligible Adult Patients with Iron Deficiency Anemia
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

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.