The U.S. Food and Drug Administration has approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose generic treatment for acute uncomplicated influenza. Approved ahead of the 2026–2027 flu season, the drug is indicated for patients 5 years of age and older, both for treatment of symptomatic influenza within 48 hours and for post-exposure prophylaxis following contact with an infected individual.

“Today’s approval marks a meaningful milestone for the treatment of influenza,” said Dr. Iilun Murphy, Director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research. “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 U.S. each year.”

Generic baloxavir marboxil is contraindicated in patients with a known history of hypersensitivity to the drug or any of its ingredients. The labeling carries a warning regarding an increased incidence of treatment-emergent resistance in patients under 5 years of age. The most common side effects include diarrhea, bronchitis, nausea, sinusitis, and headache.

The FDA approved Norwich Pharmaceuticals, Inc.’s application for the generic.

Source: FDA Press Release