OSAKA, Japan & FLORHAM PARK, N.J.–(BUSINESS WIRE)–OSAKA, Japan & FLORHAM PARK, N.J.–(BUSINESS WIRE)–Shionogi & Co., Ltd. (hereafter “Shionogi”) today announced FETROJA® (cefiderocol) is now available in the U.S. for patients 18 years of age or older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, caused by the following susceptible Gram-negative microorganisms: Escherichia coli (E. coli), Klebsiella pneumoniae (K. pneumoniae), Proteus mirabilis (P. mirabilis), Pseudomonas aeruginosa (P. aeruginosa),
and Enterobacter cloacae (E. cloacae) complex. FETROJA, which was approved by the U.S. Food and Drug Administration on November 14, 2019, is the first approved antibiotic that functions as a siderophore and has the ability to overcome many of the resistance mechanisms that Gram-negative bacteria employ against antibiotics. Under FETROJA’s Qualified Infectious Disease Product (QIDP) status, approval of the cUTI indication was based on limited clinical safety and efficacy data.
About FETROJA® (cefiderocol) for injection
Important Safety Information
Warnings and Precautions
Increase in All-Cause Mortality in Patients with Carbapenem-Resistant Gram-Negative Bacterial Infections
Clostridioides difficile-associated Diarrhea (CDAD)
Seizures and Other Central Nervous System (CNS) Adverse Reactions
Development of Drug-Resistant Bacteria
Report side effects to the FDA at 1-800-FDA-1088 or https://www.fda.gov/medwatch. Report side effects to Shionogi Inc. at 1-800-849-9707.
Indications and Usage
Shionogi’s Commitment to Fighting Antimicrobial Resistance
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- 7 Centers for Disease Control and Prevention (CDC). Antibiotic Resistance Threats in the United States 2019, Atlanta, GA: U.S. Department of Health and Human Services, CDC; 2019. Retrieved fromhttps://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf.
- 8 O’Neill J. ‘Tackling Drug-Resistant Infections Globally: Final Report and Recommendations’. Review on Antimicrobial Resistance. May 2016. Retrieved from https://amr-review.org/sites/default/files/160518_Final%20paper_with%20cover.pdf.
- 9 FETROJA® (cefiderocol) prescribing information. Florham Park, N.J. Shionogi Inc.: November 2019.
- 10 Shionogi & Co, Ltd. Shionogi announces submission of cefiderocol marketing authorisation application. April 1, 2019. Retrieved from http://www.shionogi.co.jp/en/company/news/2019/e_190401_2.pdf.
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