FDA delays PDUFA date for AMAG's Feraheme

AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) said FDA extended the PDUFA date by three months for an sNDA for anemia drug Feraheme ferumoxytol. The new date is Jan. 21, 2014; it was Oct. 21. The IV iron replacement therapy is under review to expand Feraheme's indication to include the treatment of all adult patients with iron deficiency anemia who have failed or could not tolerate oral iron treatment. Feraheme is approved to treat iron deficiency anemia in adult patients with chronic kidney disease (CKD). ...