Ferric Carboxymaltose Injection

FDA Drug Profile — Injectafer, Ferric Carboxymaltose

Ferric Carboxymaltose Injection is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand names including Injectafer, Ferric Carboxymaltose. Available dosage form: injection, solution.

Drug Details

Generic Name
Ferric Carboxymaltose Injection
Brand Names
Injectafer, Ferric Carboxymaltose
Application Number
NDA203565
Sponsor
American Regent, Inc.
NDC Codes
3
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
FERRIC CARBOXYMALTOSE

Indications and Usage

1 INDICATIONS AND USAGE Injectafer is indicated for the treatment of: • iron deficiency anemia (IDA) in: adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron. adult patients who have non-dialysis dependent chronic kidney disease. • iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity. Injectafer is an iron replacement product indicated for the treatment of: • iron deficiency anemia (IDA) in: adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron. ( 1 ) adult patients who have non-dialysis dependent chronic kidney disease. ( 1 ) • iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity. ( 1 )