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AMAG Pharmaceuticals Inc Receives Notice of Three-month Extension of PDUFA Action Date for Supplemental New Drug Application for Feraheme for Broader IDA Indication


Wednesday, 16 Oct 2013 09:30pm EDT 

AMAG Pharmaceuticals Inc 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. 

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3 Sep 2015