Medicine

FDA Approves First Prescription Oral Iron Medicine for Pediatric Patients 10 and Older

FDA approved Accrufer capsules for pediatric patients ages 10 and older with iron deficiency.

Cedar S. Insights Editorial Desk

22 December 20254 min read

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FDA approved Accrufer, ferric maltol capsules, to treat iron deficiency in pediatric patients ages 10 and older.

Accrufer had previously been approved for adults, and the pediatric indication gives clinicians another prescription oral option for older children and adolescents.

Iron deficiency is common and can affect development, energy and health, so route, tolerability and access matter.

Why It Matters

Pediatric label expansions can widen access to therapies for common conditions, not only rare diseases.

What to Watch

Watch adoption, tolerability data and payer coverage for pediatric use.

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Topics

FDAIron DeficiencyPediatricsDrug Approval