FDA Accepts Shionogi's Supplemental New Drug Application for Fetroja (cefiderocol) for Pediatric Patients with Serious Gram-negative Infections

The U.S. Food and Drug Administration (FDA) has accepted a Supplemental New Drug Application (sNDA) for Fetroja (cefiderocol) to treat pediatric patients (at least 26 weeks gestational age) with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) and complicated urinary tract infections (cUTI) caused by susceptible Gram-negative bacteria. This submission aims to address a critical therapeutic gap for vulnerable young patients facing drug-resistant pathogens, with an action date set for February 23, 2027.