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ARTICLE | Company News

AMAG slips on Feraheme sNDA update

January 10, 2014 1:59 AM UTC

AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) was off $3.58 (15%) to $20.37 on Thursday after disclosing in an SEC filing that FDA has not yet discussed proposed labeling or postmarketing requirements with AMAG for Feraheme ferumoxytol, despite the upcoming PDUFA date for an sNDA for the anemia drug. AMAG is seeking to expand Feraheme's label to include the treatment of all adult patients with iron deficiency anemia who have failed or could not tolerate oral iron treatment. ...