Feraheme FDA Approval History
FDA Approved: Yes (First approved June 30, 2009)
Brand name: Feraheme
Generic name: ferumoxytol
Dosage form: Intravenous Injection
Company: AMAG Pharmaceuticals, Inc.
Treatment for: Anemia Associated with Chronic Renal Failure, Iron Deficiency Anemia
Feraheme (ferumoxytol) is an iron replacement therapy for the treatment of iron deficiency anemia in adult patients.
Development timeline for Feraheme
| Date | Article |
|---|
| Feb 5, 2018 | Approval AMAG Pharmaceuticals Announces FDA Approval of Feraheme (ferumoxytol injection) for All Eligible Adult Patients with Iron Deficiency Anemia |
| Jun 30, 2009 | Approval FDA Approves Feraheme to Treat Iron Deficiency Anemia in Adult Chronic Kidney Disease Patients |
| May 12, 2009 | AMAG Pharmaceuticals Announces New PDUFA Date for Feraheme (ferumoxytol injection) |
| Dec 23, 2008 | AMAG Pharmaceuticals Receives Complete Response Letter from the FDA for Ferumoxytol |
| Nov 13, 2008 | AMAG Pharmaceuticals Announces Ferumoxytol Resubmission Designated Complete, Class 1 Response by the FDA |
| Oct 20, 2008 | AMAG Pharmaceuticals Receives Complete Response Letter from FDA for Ferumoxytol |
| Feb 19, 2008 | AMAG Pharmaceuticals, Inc. Announces FDA Acceptance for Filing of
Ferumoxytol New Drug Application in Chronic Kidney Disease |
| Dec 19, 2007 | AMAG Pharmaceuticals, Inc. Submits New Drug Application to FDA for
Ferumoxytol in Chronic Kidney Disease Patients |
Further information
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