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Monoferric FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

FDA Approved: Yes (First approved January 16, 2020)
Brand name: Monoferric
Generic name: ferric derisomaltose
Dosage form: Injection
Company: Pharmacosmos Therapeutics Inc.
Treatment for: Iron Deficiency Anemia

Monoferric (ferric derisomaltose) is an intravenous iron replacement product indicated for the treatment of iron deficiency anemia.

  • Monoferric is indicated for the treatment of iron deficiency anemia (IDA) in adult patients who have an intolerance to oral iron or have had unsatisfactory response to oral iron, or who have non-hemodialysis dependent chronic kidney disease.
  • Monoferric is a single-dose therapy administered as an intravenous infusion.
  • Serious hypersensitivity reactions, including anaphylactic-type reactions have been reported in patients receiving Monoferric. Patients should be monitored for signs and symptoms of hypersensitivity during and after Monoferric administration for at least 30 minutes and until clinically stable following completion of the infusion.
  • Most commonly reported adverse reactions (incidence ≥1%) are rash and nausea.

Development Timeline for Monoferric

DateArticle
Jan 29, 2020Approval  FDA Approves Monoferric (ferric derisomaltose) Injection for the Treatment of Iron Deficiency Anemia

Further information

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