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Biotech / Medical : momo-T/FIF -- Ignore unavailable to you. Want to Upgrade?


To: Robohogs who wrote (6903)4/10/2008 9:00:02 AM
From: rkrw  Respond to of 12215
 
Late October per pr:

Press Release Source: AMAG Pharmaceuticals

AMAG Pharmaceuticals, Inc. Announces FDA Acceptance for Filing of Ferumoxytol New Drug Application in Chronic Kidney Disease
Tuesday February 19, 8:29 am ET

CAMBRIDGE, Mass.--(BUSINESS WIRE)--AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG - News) today announced that the New Drug Application (NDA) for ferumoxytol in chronic kidney disease (CKD) has been accepted for standard review by the U.S. Food and Drug Administration (FDA). The Company is seeking marketing approval for ferumoxytol as an intravenous treatment of iron deficiency anemia in patients with CKD, including dialysis dependent and non-dialysis dependent patients. The Company expects FDA action on the NDA by late October 2008.