AMAG Pharmaceuticals, Inc. Announces FDA Submission of a Supplemental New Drug Application for Feraheme
Published: Dec 27, 2012
LEXINGTON, Mass.--(BUSINESS WIRE)--AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that it has submitted a supplemental new drug application (sNDA) to the United States Food and Drug Administration (FDA) for Feraheme® (ferumoxytol) Injection for Intravenous (IV) use. The sNDA requests FDA approval to expand the indication for ferumoxytol beyond the current indication for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD) to all adult patients with IDA who have failed or could not tolerate oral iron treatment. The application includes data from two well-controlled phase III clinical trials of more than 1,400 patients.