FDA Approves First Generic Single-Dose Influenza Treatment

The US FDA has approved the first generic version of baloxavir marboxil (Xofluza), a single-dose oral antiviral for influenza. It is indicated for the treatment of acute uncomplicated influenza in adults and children 5 years and older who have had symptoms for 48 hours or less, as well as for post-exposure prophylaxis after close contact with someone infected with influenza. Expected to be available for the 2026–2027 flu season, the generic formulation is likely to improve accessibility and affordability while maintaining the convenience of a single-dose treatment.

“Today’s approval marks a meaningful milestone for the treatment of influenza,” said Iilun Murphy, M.D., 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 tablets may be used for:

• Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours, and who are otherwise healthy or at high risk of developing influenza-related complications; and

• Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza.

Baloxavir marboxil tablets are contraindicated in patients with a known history of hypersensitivity reactions to baloxavir marboxil or any of its ingredients. Baloxavir marboxil carries warnings such as increased incidence of treatment-emergent resistance in patients less than 5 years of age.

The most common side effects include diarrhea, bronchitis, nausea, sinusitis, and headaches. Healthcare providers should review the full prescribing information for complete safety and dosing information.

In the U.S., nine out of 10 prescriptions filled are for generic drugs. Increasing the availability of generic drugs helps to create competition in the marketplace, which then helps to make treatment more affordable and increases access to healthcare for more patients.