WALTHAM, Mass., Oct. 16, 2013 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG) today announced that the U.S. Food and Drug Administration (FDA) has extended its review of a supplemental new drug application (sNDA) for Feraheme® (ferumoxytol) injection for intravenous (IV) use. The sNDA seeks to expand the indication for Feraheme beyond the current indication for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD) to include all adult patients with IDA who have failed or cannot tolerate oral iron treatment. The new prescription drug user fee act (PDUFA) action date has been set for January 21, 2014.
AMAG Pharmaceuticals Receives Notice Of 3-month Extension Of The PDUFA Action Date For The Supplemental New Drug Application For Feraheme(R) For The Broader IDA Indication
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