AMAG Pharmaceuticals, Inc announced that the US Food and Drug Administration (FDA) has designated the company's resubmission to the October 2008 Complete Response letter for its New Drug Application (NDA) for ferumoxytol as a complete, class 1 response. The FDA has established a December 30, 2008 Prescription Drug User Fee Act (PDUFA) target action date. AMAG is seeking marketing approval for ferumoxytol for the treatment of iron deficiency anaemia in patients with all stages of chronic kidney disease (CKD), including those on dialysis and those not on dialysis.
"We are pleased that the FDA has designated our resubmission as a complete, class 1 response," stated Brian J G Pereira, president and chief executive officer of AMAG Pharmaceuticals, Inc. "We look forward to continuing to work with the Agency to complete the review of the ferumoxytol resubmission. We plan to launch ferumoxytol shortly after we receive approval."
AMAG Pharma is a biopharmaceutical company that utilizes its proprietary technology for the development and commercialization of a therapeutic iron compound to treat anaemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease.
Ferumoxytol is being developed for use as an intravenous iron replacement therapeutic agent for the treatment of iron deficiency anaemia and as a diagnostic agent for vascular-enhanced magnetic resonance imaging to assess peripheral arterial disease.