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A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia

Trial Profile

A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Jun 2018

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At a glance

  • Drugs Ferumoxytol (Primary)
  • Indications Iron deficiency anaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors AMAG Pharmaceuticals
  • Most Recent Events

    • 05 Feb 2018 According to an AMAG Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has approved sNDA application to broaden the existing label for Feraheme (ferumoxytol injection) beyond the current chronic kidney disease (CKD) indication to include all eligible adult Iron Deficiency Anemia (IDA) patients who have intolerance to oral iron or have had unsatisfactory response to oral iron. Data from this and two other phase 3 trials supported the submission.
    • 02 Dec 2013 New trial record
    • 14 Oct 2013 Results of a subgroup analysis presented at the Annual Scientific Meeting of the American College of Gastroenterology (ACG).
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