Ferric Carboxymaltose Receives US FDA Approval for the Treatment of Iron Deficiency Anemia

On July 25, 2013, American Regent Inc., a subsidiary of Luitpold Pharmaceuticals Inc., announced that Injectafer® (ferric carboxymaltose injection) has received U.S. Food and Drug Administration (FDA) approval. Injectafer® is a parenteral iron replacement product used for the treatment of iron deficiency anemia in adult patients who have intolerance to oral iron or have had an unsatisfactory response to oral iron. Injectafer® is also indicated for iron deficiency anemia in adult patients with non-dialysis dependent chronic kidney disease.

A single dose of up to 750 mg of Injectafer® can be administered undiluted as an IV push injection at a rate of 100 mg/minute or as an IV infusion in up to 250 mL 0.9 % Sodium Chloride Injection, USP, over at least 15 minutes. The safety and efficacy of Injectafer® for treatment of iron deficiency anemia were evaluated in two clinical trials (Trial 1 and Trial 2) in which Injectafer® was administered at a dose of 15 mg/kg body weight up to a maximum single dose of 750 mg of iron on two occasions separated by at least 7 days up to a maximum cumulative dose of 1500 mg of iron. The entire Injectafer® program consisted of over 11,071 patients treated with the study product or a comparator. This represents the largest safety database ever submitted to the FDA to support the approval of an IV iron product.

Injectafer® is manufactured and marketed under the name of Ferinject® (Ferric Carboxymaltose) by Vifor Pharma (Switzerland) outside of North America. Ferinject® is currently registered in 46 countries and is marketed in 37 countries worldwide.

Source: American Regent, Inc. [Link]

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