FDA OKs first generic single-dose flu treatment

On June 17, 2026, FDA approved the first generic version of Xofluza (baloxavir marboxil) tablets for treatment of acute uncomplicated influenza in patients aged five years and older who've been symptomatic for no more than 48 hours and are otherwise healthy or at high risk for influenza-related complications. The generic is also approved for post-exposure prophylaxis in patients aged five years and older after contact with someone who has influenza.

Baloxavir is given as a single oral dose, offering a simpler option for patients who may have difficulty completing multi-day antiviral regimens. As the first generic version of Xofluza, it may also improve affordability ahead of the 2026-2027 influenza season. Clinicians should still emphasize prompt initiation, since antiviral benefit is greatest when treatment begins soon after symptom onset.

Common adverse effects include diarrhea, bronchitis, nausea, sinusitis, and headache. Baloxavir is contraindicated in patients with a known history of hypersensitivity to baloxavir marboxil or any of its ingredients. The label notes a higher incidence of treatment-emergent resistance in children younger than five years.

“Expanding patient access to drugs and improving their ease of use are critical public health imperatives, particularly given that influenza alone accounts for millions of illnesses in the US each year,” said Iilun Murphy, MD, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research.

Source: FDA. 2026 June 17. [Press release]. FDA approves first single-dose generic treatment for influenza