UPDATE: AMAG Pharmaceuticals Receives CRL from FDA for Supplemental NDA for Feraheme for Broader IDA Indication

AMAG Pharmaceuticals

today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the supplemental new drug application (sNDA) for Feraheme® (ferumoxytol) injection for intravenous (IV) use. The sNDA sought to expand the indication for Feraheme beyond the current chronic kidney disease (CKD) indication to include all adult iron deficiency anemia (IDA) patients who have failed or cannot tolerate oral iron treatment.