FDA Accepts Shionogi’s sNDA for Fetroja® (cefiderocol) for Use in Pediatric Patients with Serious Infections Caused by Susceptible Gram-negative Bacteria

Shionogi Inc., a New Jersey-based subsidiary of Shionogi & Co., Ltd., announced the U.S. Food and Drug Administration (FDA) has accepted a Supplemental New Drug Application (sNDA) for Fetroja^® (cefiderocol) for the treatment of pediatric patients (at least 26 weeks of gestational age) with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) and complicated urinary tract infections (cUTI), including pyelonephritis, caused by certain Gram-negative microorganisms.