Skip to main content

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.

Development timeline for Fetroja

DateArticle
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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.