Feraheme 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 History and FDA Approval Process for Feraheme
|Feb 5, 2018|| AMAG Pharmaceuticals Announces FDA Approval of Feraheme (ferumoxytol injection) for All Eligible Adult Patients with Iron Deficiency Anemia|
|Jun 30, 2009|| 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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