FDA Approves American Regent’s Injectafer for Pediatric Patients

American Regent, a Daiichi Sankyo Group company specializing in injectables manufacturing, announced on Dec. 16, 2021, that FDA approved Injectafer for pediatric patients with iron deficiency anemia (IDA) aged one or older. This approval provides an alternative means of treatment for patients who cannot take oral iron.

Injectafer is an iron replacement product originally approved by FDA for adults in 2013. Treatment consists of a two-dose intravenous injection of 750 mg separated by at least seven days. In patients weighing less than 50 kg (110 lb), this dosage is adjusted to 15 mg/kg of body weight.

"We are pleased to build on the effective and proven treatment of Injectafer for adult IDA patients with the approval of this new pediatric use," said Linda Mundy, chief medical officer at American Regent, in a company press release. "More than 1.7 million adult patients have been treated with Injectafer in the U.S. Pediatric healthcare providers now have an option for pediatric patients as young as one year of age with IDA who are intolerant to oral iron or who have had an unsatisfactory response to oral iron.”