American Regent, a subsidiary of a Daiichi Sankyo Group Company named Luitpold Pharmaceuticals, has won USFDA approval for Injectafer (ferric carboxymaltose injection) for the treatment of iron deficiency anemia (IDA).
A parenteral iron replacement product, Injectafer is indicated for IDA treatment in adult patients who are intolerant to oral iron or do not respond to oral iron and in adults with non-dialysis dependent chronic kidney disease (NND-CKD).
American Regent president and CEO Mary Jane Helenek said Injectafer is approved as the first high dose non-dextran IV iron indicated to treat adult patients with iron deficiency anaemia in a broad patient population.
"Now, with Injectafer, physicians can effectively and efficiently treat these patients with a single dose of up to 750 mg of iron via an IV push injection or over a 15 minute infusion followed by a second dose 7 days later for a total treatment of up to 1500 mg of iron," Jane Helenek added.
A single dose of up to 750mg of Injectafer can be administered undiluted as an IV push injection at a rate of 100mg/minute or as an IV infusion in up to 250ml 0.9 % Sodium Chloride Injection, USP, over 15 minutes, according to the company.
Manufactured and marketed as Ferinject (Ferric Carboxymaltose) by Vifor Pharma (Switzerland) outside of North America, Injectafer is currently registered in 46 countries and is globally marketed in 37 countries.
