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# Shionogi Urinary Tract Infection Drug Approved
- URL: https://www.fdaweb.com/shionogi-urinary-tract-infection-drug-approved/
- Published: 2019-11-15T12:00:00.000Z
- Updated: 2026-09-14T15:53:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145522

FDA has approved a Shionogi & Co. NDA for Fetroja (cefiderocol), an antibacterial drug for treating patients 18 years of age or older with complicated urinary tract infections (cUTI), including kidney infections caused by susceptible Gram-negative microorganisms, who have limited or no alternative treatment options. Approval is based on data from a study of 448 patients with cUTIs. “Of the patients who were administered Fetroja, 72.6% had resolution of symptoms and eradication of the bacteria approximately seven days after completing treatment, compared with 54.6% in patients who received an alternative antibiotic,” an [agency release](https://www.fda.gov/news-events/press-announcements/fda-approves-new-antibacterial-drug-treat-complicated-urinary-tract-infections-part-ongoing-efforts?ref=fdaweb.com) says. “The clinical response rates were similar between the two treatment groups.”