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Accrufer FDA Approval History

FDA Approved: Yes (First approved July 25, 2019)
Brand name: Accrufer
Generic name: ferric maltol
Dosage form: Capsules
Previous Name: Feraccru
Company: Shield Therapeutics plc
Treatment for: Iron Deficiency

Accrufer (ferric maltol) is a non-salt formulation of ferric iron for the treatment of iron deficiency in adults.

  • Accrufer capsules are taken twice daily on an empty stomach, at least one hour before or two hours after meals.
  • Accrufer may decrease the the bioavailability of some oral medications and administration times may need to be separated. Concomitant use with dimercaprol should be avoided.
  • Common adverse reactions (incidence >1%) include flatulence, diarrhea, constipation, discolored feces, abdominal pain, nausea, vomiting, and abdominal discomfort or bloating.

Development Timeline for Accrufer

Jul 26, 2019Approval FDA Approves Accrufer (ferric maltol) for the Treatment of Iron Deficiency in Adults
Dec  3, 2018Shield Therapeutics Announces the NDA for Feraccru has been Accepted for Filing and Review by FDA
Oct  1, 2018Shield Therapeutics Announces Submission of a New Drug Application (NDA) for Feraccru for the treatment of Iron Deficiency

Further information

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