AMAG Pharmaceuticals, Inc. Announces FDA Acceptance of Supplemental New Drug Application for Feraheme Label Expansion to Include Iron Deficiency Anemia Patients Who Cannot Take Oral Iron
Published: Mar 06, 2013
LEXINGTON, Mass.--(BUSINESS WIRE)--AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that the United States Food and Drug Administration (FDA) has accepted for review the company’s supplemental new drug application (sNDA) for Feraheme® (ferumoxytol) Injection for Intravenous (IV) use, which was submitted to the FDA in December 2012. 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 adult patients with IDA who have failed or could not take oral iron treatment. Under the Prescription Drug User Fee Act (PDUFA) guidelines, the sNDA is subject to a 10-month review by the FDA. With the acceptance of the submission, the FDA has set October 21, 2013 as a target date for completion of their review.