Posted by Michael Wonder on 18 Jul 2026
FDA accepts Shionogi’s sNDA for Fetroja (cefiderocol) for use in pediatric patients with serious infections caused by susceptible gram negative bacteria submission intends to address a critical therapeutic gap for vulnerable young patients facing drug-resistant pathogens
17 July 2026 - Shionogi announced the US FDA has accepted a Supplemental new drug application for Fetroja (cefiderocol) for the treatment of pediatric patients (at least 26 weeks of gestational age) with hospital-acquired and ventilator-associated bacterial pneumonia and complicated urinary tract infections, including pyelonephritis, caused by certain Gram-negative microorganisms.
The FDA has set an action date of 23 February 2027 under the Prescription Drug User Fee Act.
