17 Nov 08 Ferumoxytol Resubmission Designated Complete, Class 1 Response By FDA - Iron Deficiency Anemia In Chronic Kidney Disease Patients
AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the U.S. Food and Drug Administration (FDA) has designated the Company’s resubmission to the October 2008 Complete Response letter for its New Drug Application (NDA) for ferumoxytol as a complete, Class 1 response. The FDA has established a December 30, 2008 Prescription Drug User Fee Act (PDUFA) target action date.
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