June 22, 2026- The U.S. Food and Drug Administration approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment for acute uncomplicated influenza and prophylaxis in patients 5 years of age and older, approved in time for the 2026–2027 flu season.
Generic baloxavir marboxil tablets may be used for:
- Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours, and who are otherwise healthy or at high risk of developing influenza-related complications; and
- Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza.
Continue Reading from the FDA.