FDA Approves First Single-Dose Generic Flu Treatment, Baloxavir Marboxil

The U.S. Food and Drug Administration (FDA) has approved the first generic version of baloxavir marboxil, a single-dose oral treatment for acute uncomplicated influenza and post-exposure prophylaxis in individuals aged 5 and older. This approval, granted to Norwich Pharmaceuticals, aims to expand patient access to flu treatment and is timed in preparation for the 2026-2027 flu season. Baloxavir marboxil was originally approved in 2018 as Xofluza (Genentech) and must be prescribed within 48 hours of symptom onset for treatment.