Kidney Disease
AMAG Pharmaceuticals, Inc. Announces FDA Acceptance for Filing of Ferumoxytol New Drug Application in Chronic Kidney Disease
Published in Medical Letter on the CDC and FDA, March 9th, 2008
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) 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.
The NDA is supported by data from four Phase III studies, which consisted of three open-label, multi-center, randomized efficacy and safety clinical studies and a fourth double-blind,...
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