Shionogi & Co. gets FDA green light for Fetroja

Shionogi & Co. has received the Food and Drug Administration’s approval for Fetroja (cefiderocol), an antibacterial drug for treatment of patients 18 years of age or older with complicated urinary tract infections, including kidney infections caused by susceptible Gram-negative microorganisms, who have limited or no alternative treatment options.

“Today’s approval provides an additional treatment option for patients with [complicated urinary tract infections] who have limited or no alternative treatment options,” said John Farley, acting director of the office of infectious diseases in the FDA’s center for drug evaluation and research.

“A key global challenge the FDA faces as a public health agency is addressing the threat of antimicrobial-resistant infections, like [complicated urinary tract infections]," Farley said. "This approval represents another step forward in the FDA’s overall efforts to ensure safe and effective antimicrobial drugs are available to patients for treating infections."