AMAG Pharmaceuticals has announced that it has not received an action letter from FDA for Feraheme (ferumoxytol) Injection, for the treatment of iron deficiency anemia in adult chronic kidney disease patients.
The Prescription Drug User Fee Act (PDUFA) action date was June 29, 2009. FDA informed the company that the Agency would not take action today, but expects to issue an action letter within the next few days.
FDA has not requested any additional information from the company, and it is the company’s understanding that there are no outstanding issues regarding the Feraheme’ New Drug Application (NDA).
Feraheme (ferumoxytol) injection is being developed for use as an intravenous iron replacement therapeutic agent. It is to be used for the treatment of iron deficiency anemia and as a diagnostic agent for vascular-enhanced magnetic resonance imaging, to assess peripheral arterial disease.