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Fetroja FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 28, 2020.

FDA Approved: Yes (First approved November 14, 2019)
Brand name: Fetroja
Generic name: cefiderocol
Dosage form: Injection
Company: Shionogi Inc.
Treatment for: Complicated Urinary Tract Infections; Hospital-acquired Bacterial Pneumonia; Ventilator-associated Bacterial Pneumonia

Fetroja (cefiderocol) is a siderophore cephalosporin indicated for the treatment of complicated urinary tract infections (cUTI), hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible Gram-negative microorganisms.

  • Cefiderocol is a novel antibiotic that works by acting like a Trojan horse. The drug acts as a siderophore, binding to ferric iron to penetrate the outer cell membrane of Gram-negative pathogens taking advantage of the bacteria‚Äôs need for iron to survive.
  • Fetroja is administered every 8 hours via intravenous (IV) infusion.
  • Patients receiving Fetroja should be aware of the possibility of serious allergic reactions, potentially serious diarrhea (Clostridium difficile-associated diarrhea), and central nervous system (CNS) adverse reactions including seizures.
  • Common adverse reactions in patients treated for cUTI include diarrhea, infusion site reactions, constipation, rash, candidiasis, cough, elevations in liver tests, headache, hypokalemia, nausea, and vomiting.
  • Common adverse reactions in patients treated for HABP/VABP include elevations in liver tests, hypokalemia, diarrhea, hypomagnesemia, and atrial fibrillation.

Development timeline for Fetroja

Sep 28, 2020Approval FDA Approves Fetroja (cefiderocol) for the Treatment of Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia
Nov 14, 2019Approval FDA Approves Fetroja (cefiderocol) for the Treatment of Complicated Urinary Tract Infections
Oct 16, 2019U.S. FDA Advisory Committee Recommends Approval of Cefiderocol for Treatment of Complicated Urinary Tract Infections
Oct  2, 2019Shionogi Reports Positive Results from Cefiderocol Phase III Study in Adults with Pneumonia Caused by Gram-negative Pathogens

Further information

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