AMAG Pharmaceuticals, Inc. Announces New PDUFA Date for Feraheme (ferumoxytol injection)
Published: May 13, 2009
LEXINGTON, Mass.--(BUSINESS WIRE)--AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG - News), 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.
AMAG Pharmaceuticals, Inc. Kristen Galfetti, 617-498-3362