WASHINGTON, D.C. — The U.S. Food and Drug Administration has approved the first generic version of Xofluza (baloxavir marboxil), expanding access to a single-dose influenza treatment and prevention option ahead of the 2026–2027 flu season.
The approval allows generic baloxavir marboxil tablets to be marketed for the treatment of acute uncomplicated influenza and for post-exposure prevention in patients age 5 and older, the agency announced.
The decision adds competition to a market where antiviral treatment options remain important during seasonal flu outbreaks that affect millions of Americans each year. FDA officials also highlighted the broader role generic drugs play in lowering costs and expanding patient access.
“Today’s approval marks a meaningful milestone for the treatment of influenza,” Iilun Murphy, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research, stated. “Expanding patient access to drugs and improving their ease of use are critical public health imperatives.”
Baloxavir marboxil is the first single-dose influenza treatment approved for both treatment and post-exposure prophylaxis. The generic version may be used to treat patients who have experienced flu symptoms for no more than 48 hours and who are either otherwise healthy or at elevated risk for influenza-related complications.
The medication may also be prescribed to help prevent influenza following exposure to an infected individual.
FDA officials noted that approximately 90% of prescriptions filled in the United States are for generic medications. Increased generic availability can help create additional marketplace competition and improve affordability for patients.
The agency cautioned that baloxavir marboxil should not be used in patients with a known hypersensitivity to the drug or its ingredients. The prescribing information also includes warnings regarding an increased incidence of treatment-emergent resistance among younger pediatric patients.
The most commonly reported adverse reactions include diarrhea, bronchitis, nausea, sinusitis, and headache.
The approval was granted to Norwich Pharmaceuticals Inc. Xofluza is marketed by Genentech Inc.
Additional information on generic drug approvals and the FDA’s Drug Competition Action Plan is available at fda.gov.
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