FDA approves first generic single-dose baloxavir tablet for flu treatment and prevention
FDA announced approval of the first generic version of Xofluza (baloxavir marboxil) tablets, a single-dose treatment for acute uncomplicated influenza and prophylaxis for patients five years of age and older.
The approval arrives ahead of the 2026-2027 flu season and is highlighted as part of the administration’s push to expand generic drug availability.
The generic tablets may be used to treat flu symptoms that started within 48 hours in otherwise healthy or high-risk patients, and for post-exposure prophylaxis after contact with an infected individual. They are contraindicated in patients with known hypersensitivity to baloxavir marboxil.
This writeup was produced by pharmadog from original reporting by fda press.
Original headline: “FDA Approves First Single-Dose Generic Treatment for Influenza”
read at fda press ↗
comments(0)
5-min edit window · permanent after that