Feraheme
Generic name: ferumoxytol
Treatment for: Anemia Due to Chronic Kidney Disease, Iron Deficiency Anemia
AMAG Pharmaceuticals Announces New PDUFA Date for Feraheme (ferumoxytol injection)
LEXINGTON, Mass.--(BUSINESS WIRE)--May 12, 2009 - AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's resubmission of its Feraheme(ferumoxytol injection) New Drug Application in response to the December 2008 Complete Response letter as a complete, Class 1 response. In addition, the FDA has established June 29, 2009 as its target action date under the Prescription Drug User Fee Act (PDUFA) to complete its review. The Company is seeking marketing approval of its iron replacement therapy, Feraheme, to treat iron deficiency anemia in chronic kidney disease patients.
About AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that utilizes its proprietary technology for the development and commercialization of a therapeutic iron compound to treat anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease.
Feraheme (ferumoxytol injection) is being developed for use as an intravenous iron replacement therapeutic agent for the treatment of iron deficiency anemia and as a diagnostic agent for vascular-enhanced magnetic resonance imaging to assess peripheral arterial disease.
Contact: AMAG Pharmaceuticals, Inc.
Kristen Galfetti, 617-498-3362
Posted: May 2009
Related articles
- AMAG Pharmaceuticals Announces FDA Approval of Feraheme (ferumoxytol injection) for All Eligible Adult Patients with Iron Deficiency Anemia - February 5, 2018
- FDA Approves Feraheme to Treat Iron Deficiency Anemia in Adult Chronic Kidney Disease Patients - June 30, 2009
- AMAG Pharmaceuticals Receives Complete Response Letter from the FDA for Ferumoxytol - December 23, 2008
- AMAG Pharmaceuticals Announces Ferumoxytol Resubmission Designated Complete, Class 1 Response by the FDA - November 13, 2008
- AMAG Pharmaceuticals Receives Complete Response Letter from FDA for Ferumoxytol - October 20, 2008
- AMAG Pharmaceuticals, Inc. Announces FDA Acceptance for Filing of Ferumoxytol New Drug Application in Chronic Kidney Disease - February 19, 2008
- AMAG Pharmaceuticals, Inc. Submits New Drug Application to FDA for Ferumoxytol in Chronic Kidney Disease Patients - December 19, 2007
Feraheme (ferumoxytol) FDA Approval History
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