USFDA approves Monoferric injection for treatment of iron deficiency anemia

USA: The U.S. Food and Drug Administration (FDA) has approved Pharmacosmos Therapeutics' Monoferric (ferric derisomaltose) injection 100 mg/mL. Monoferric, a complex of iron (III) hydroxide and derisomaltose, is indicated for the treatment of iron deficiency anemia (IDA) in adult patients intolerant to oral iron or those who had an unsatisfactory response to oral iron, or who have non-hemodialysis dependent chronic kidney disease.

The WHO states that iron deficiency is the most common and widespread nutritional disorder in the world and is the most common cause of anemia globally. It affects a large number of children and women in non-industrialized countries and is the only nutrient deficiency which is also significantly prevalent in virtually all industrialized nations. 

"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 the 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."