Posted by Michael Wonder on 05 Feb 2018
AMAG Pharmaceuticals announces FDA approval of supplemental new drug application for Feraheme (ferumoxytol injection)
5 February 2018 - Feraheme is now a treatment option for all eligible adult patients with iron deficiency anaemia.
AMAG Pharmaceuticals today announced that the U.S. FDA has approved its application to broaden the existing label for Feraheme (ferumoxytol injection) beyond the current chronic kidney disease (CKD) indication to include all eligible adult iron deficiency anaemia patients who have intolerance to oral iron or have had unsatisfactory response to oral iron.
This approval immediately doubles the number of patients who could benefit from Feraheme to include both CKD and non-CKD patients.
