Amag submits new drug application

Amag Pharmaceuticals Inc. said today announced that it has submitted a New Drug Application to the US Food and Drug Administration.

The application is for marketing approval of ferumoxytol as an intravenous treatment of iron deficiency anemia in patients with chronic kidney disease, including dialysis dependent and non-dialysis dependent patients, the Cambridge company said.

The application is supported by data from three open-label, multi-center, randomized Phase III efficacy and safety clinical studies and a fourth Phase III safety study, said Amag, which noted that more than 1,700 patients and healthy volunteers were treated with ferumoxytol in its 11 clinical studies.
(By Chris Reidy, Globe staff)