BioCentury
ARTICLE | Company News

AMAG falls on Feraheme update

September 26, 2013 1:11 AM UTC

AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) was off $3.74 (14%) to $22.42 on Wednesday after disclosing in an 8-K that it received a notification from FDA that the agency identified "deficiencies" in an sNDA for anemia drug Feraheme ferumoxytol that prevented the agency from discussing potential labeling or postmarket requirements by its Sept. 23 target date. The IV iron replacement therapy has an Oct. 21 PDUFA date and is under review to expand the indication to include the treatment of all adult patients with iron deficiency anemia who have failed or could not tolerate oral iron treatment. AMAG said FDA did not disclose the deficiencies, but that the company plans to work with the agency to resolve outstanding issues. Feraheme is approved to treat iron deficiency anemia in adult patients with chronic kidney disease (CKD). ...