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news.As an iron replacement therapy for treatment of iron deficiency anemia in adult patients with chronic kidney disease
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FDA has granted marketing approval for AMAG’s Feraheme (ferumoxytol) Injection. It is for intravenous (IV) use as an iron replacement therapy, for the treatment of iron deficiency anemia in adult patients with chronic kidney disease.
The recommended dose of Feraheme is an initial 510mg IV injection, followed by a second 510mg IV injection three to eight days later. Feraheme should be administered as an undiluted IV injection delivered at a rate of up to 1 mL/sec (30 mg/sec). The recommended Feraheme dose may be readministered to patients with persistent or recurrent iron deficiency anemia, said the company.
Feraheme is expected to be commercially available in the US during the second half of July 2009.
Brian Pereira, MD, President and CEO of AMAG, said: Feraheme offers patients across the continuum of chronic kidney disease, including patients not on dialysis and patients on dialysis, a new paradigm for the treatment of iron deficiency anemia. We are extremely pleased with the FDA’s approval of Feraheme, and we are well prepared and excited to bring this new treatment option to patients and physicians.