The FDA approved the first generic version of Xofluza (baloxavir marboxil) on June 17, clearing Norwich Pharmaceuticals’ single-dose influenza tablet ahead of the 2026–27 flu season.
Generic baloxavir marboxil is approved to treat acute uncomplicated influenza in patients 5 and older who have been symptomatic for no more than 48 hours. It’s also approved for post-exposure prophylaxis for the same age group.
The drug works by inhibiting a viral enzyme called cap-dependent endonuclease, a mechanism distinct from older antivirals such as Tamiflu.
The new medication will offer patients a lower-cost version of the branded Xofluza, a registered trademark of Genentech.
