AMAG Files NDA for Ferumoxytol

AMAG Pharmaceuticals has submitted a new drug application (NDA) to the FDA for the marketing approval of ferumoxytol as an intravenous treatment of anemia in patients with chronic kidney disease.

The NDA is supported by data from three open-label, multicenter, randomized Phase III efficacy and safety studies and a fourth Phase III safety study.

The studies demonstrated a statistically significant achievement of all primary and secondary endpoints. More than 1,700 subjects were treated with ferumoxytol in the company’s 11 clinical studies, according to AMAG.