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
|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|
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