DOTHAN, Ala. (WDNews) — The U.S. Food and Drug Administration has approved the first generic version of Xofluza (baloxavir marboxil) tablets, making the first single-dose treatment for influenza available in a generic form ahead of the 2026-2027 flu season.
According to the FDA, generic baloxavir marboxil tablets are approved for the treatment of acute uncomplicated influenza in patients ages 5 and older who have had flu symptoms for no more than 48 hours. The medication is approved for otherwise healthy patients as well as those at high risk of developing flu-related complications.
The drug is also approved for post-exposure prevention of influenza in patients ages 5 and older following contact with someone who has the flu.
“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 the 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.”
The FDA said baloxavir marboxil tablets are contraindicated for patients with a known history of hypersensitivity reactions to the drug or its ingredients. The medication also carries warnings, including an increased incidence of treatment-emergent resistance in younger patients.
Common side effects may include diarrhea, bronchitis, nausea, sinusitis and headaches.
According to the FDA, about 90% of prescriptions filled in the United States are for generic drugs. Officials said increasing the availability of generic medications helps create market competition, lower costs and improve access to treatment for patients.
The FDA approved the application submitted by Norwich Pharmaceuticals Inc. for generic baloxavir marboxil tablets.
