AMAG Pharmaceuticals Announces FDA Approval of Supplemental New Drug Application (sNDA) for Feraheme® (ferumoxytol injection)
AMAG PHARMACEUTICALS (AMAG)
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Source: GlobeNewswire
WALTHAM, Mass., Feb. 05, 2018 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the U.S. Food and Drug Administration (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 Anemia (IDA) patients who have intolerance to oral iron or have had unsatisfactory response to oral iron. This sNDA approval immediately doubles the number of patients who could benefit from Feraheme to include both CKD and non-CKD patients. "Iron deficiency anemia is a serious and under-treated health condition which negatively impacts quality of life for millions of people, many of whom do not benefit from or cannot tolerate oral iron therapy,” said Michael Auerbach, M.D., Clinical Professor at Georgetown University School of Medicine. "Physicians now have a new option for patients who meet the broader ferumoxytol injection indi
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