FDA approves 1st single-dose generic flu drug

Becker’s Hospital Review – Thursday, June 18, 2026
By Mackenzie Bean

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.

Click here to read the entire article.