FDA Approves American Regent’s Injectafer for Pediatric Patients

FDA approved American Regent’s Injectafer (iron carboxymaltose injection) for the treatment of pediatric patients with iron deficiency anemia.

American Regent, a Daiichi Sankyo Group company specializing in the production of injectables, announced on December 16, 2021 that the FDA has approved Ferinject for pediatric patients with iron deficiency anemia (IDA) of one or older. This approval provides an alternative treatment for patients unable to take oral iron.

Ferinject is an iron replacement product that was originally approved by the FDA for adults in 2013. Treatment consists of an intravenous injection of two doses of 750 mg at least seven days apart. In patients weighing less than 50 kg, this dose is adjusted to 15 mg/kg body weight.

“We are excited to build on the effective and proven treatment of Ferinject for adult IDA patients with the approval of this new pediatric use,” said Linda Mundy, medical director of American Regent, in a company press release. “More than 1.7 million adult patients have been treated with Ferinject in the US. Pediatric caregivers 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.”

Source: American Regent

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