Pharmacosmos Therapeutics announced the U.S. Food and Drug Administration (FDA) has approved Monoferric® (ferric derisomaltose) injection 100 mg/mL. Monoferric® is an intravenous iron indicated for the treatment of iron deficiency anemia (IDA) in adult patients who have an intolerance to oral iron or have had unsatisfactory response to oral iron, or who have non-hemodialysis dependent chronic kidney disease.
"We are very pleased with the FDA's approval of Monoferric® as the first intravenous iron product approved in the United States for the infusion of 1000 mg as a single dose in one visit for patients with iron deficiency anemia," said Michael Ryde, CEO of Pharmacosmos Therapeutics Inc. "We are excited to provide this new innovative treatment to US physicians."
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"Iron deficiency anemia remains a serious health issue both in the United States and globally," said Michael Auerbach, MD, FACP, Clinical Professor of Medicine at Georgetown University School of Medicine in Washington DC. "I am very happy that Monoferric®, which is supported by a robust clinical trial programme, is now approved in the United States for administration of a total dose infusion in a single visit, making it the first intravenous iron formulation in the United States to receive such an approval."