Shionogi’s Fetroja approved by TFDA in Taiwan

Japanese drugmaker Shionogi (TYO: 4507) today revealed that it has received approval from the Taiwan Food and Drug Administration (TFDA) for Fetroja (cefiderocol) in the treatment of complicated urinary tract infections.

These include pyelonephritis, and hospital-acquired pneumonia (including hospital-acquired bacterial pneumonia and ventilator-acquired associated bacterial pneumonia) caused by susceptible Gram-negative microorganisms. This approval applies to patients who are 18 years of age or older and have no other treatment options or limited alternatives available.

Fetroja is a siderophore cephalosporin antibiotic developed by Shionogi, and new drug application in Taiwan was filed on December 13, 2022