Ferumoxytol

Drug Profile

Ferumoxytol

Alternative Names: Feraheme; Ferrosoferric oxide; Rienso

Latest Information Update: 10 Sep 2017

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At a glance

  • Originator AMAG Pharmaceuticals
  • Class Antianaemics; Contrast media; Diagnostic agents; Ferric compounds; Ferrous compounds; Heavy metals; Minerals
  • Mechanism of Action Iron replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Iron deficiency anaemia
  • Phase II Peripheral arterial disorders

Most Recent Events

  • 31 Aug 2017 FDA assigns PDUFA action date of 02/02/2018 for ferumoxytol for Iron deficiency anaemia in patients with intolerance or unsatisfactory response to oral iron
  • 31 Aug 2017 US FDA accepts for review sNDA for label extension of Ferumoxytol for Iron deficiency anaemia in patients with intolerance or unsatisfactory response to oral iron
  • 17 Aug 2017 Chemical structure information added
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