Feraheme ferumoxytol regulatory update

AMAG said FDA accepted for review an sNDA to expand the indication for Feraheme ferumoxytol to include the treatment of all adult patients with iron deficiency anemia who have failed or could not tolerate oral iron treatment. The PDUFA date is Oct. 21. The IV iron replacement therapy is already approved to treat iron deficiency anemia in adult patients with chronic kidney disease (CKD) (see BioCentury, Jan. 7). ...