US FDA approves single dose ferric carboxymaltose injection

US FDA approves single dose ferric carboxymaltose injection

The US FDA has recently approved a new single 1000 mg dose of ferric carboxymaltose injection (Injectafer) for the treatment of iron deficiency anaemia (IDA) in adult patients.

The drug is an iron replacement therapy for IDA patients with oral iron intolerance, unsatisfactory response to oral iron, or a non-dialysis dependent chronic kidney disease. The approval was granted to Daiichi Sankyo, Inc and American Regent, Inc.

Ferric carboxymaltose injection treatment was first approved in 2013 by the FDA as a 1500 mg course. The drug was administered as 2 doses up to 750 mg, each dose separated by 7 days. This dosage is recommended for patients weighing 50 kg (110 lb) or more.

Over 40 clinical trials have studied the therapy and it is approved in 75 countries since the European Union approval in 2007. The therapy becomes an additional option for patients who may not be adherent to other treatments, says the company.