BioCentury
ARTICLE | Finance

Regulatory milestones

Regulatory, clinical and other milestones

September 30, 2013 7:00 AM UTC

AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) lost $3.74 (14%) to $22.42 on Wednesday after disclosing that FDA identified "deficiencies" in an sNDA for anemia drug Feraheme ferumoxytol that prevented the agency from discussing potential labeling or postmarket requirements with the company by Sept. 23, a target date set by the agency in March. FDA did not disclose the issues.

Feraheme is under FDA review with an Oct. 21 PDUFA date to expand its 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)...