BRIEF—FDA nod for first Rx oral med for iron deficiency in pediatric patients

24 December 2025

The US Food and Drug Administration (FDA) has approved Accrufer (ferric maltol) capsules to treat pediatric patients ages 10 and older with iron deficiency.

Shield Therapeutics’ Accrufer was initially approved in 2019 for adults with iron deficiency.

Iron deficiency is the most common cause of anemia and occurs if there is not enough iron in the blood. Without enough iron, the body cannot make sufficient hemoglobin, a protein inside red blood cells that carries oxygen throughout the body.

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