WASHINGTON — The U.S. Food and Drug Administration (FDA) has approved the first generic version of a single-dose oral influenza treatment, expanding availability of a medicine used to treat and prevent certain flu infections ahead of the 2026–2027 flu season, the agency said.
The approved product is a generic version of baloxavir marboxil tablets, the active ingredient in Xofluza, a flu antiviral originally developed as a single-dose treatment. The FDA said the generic was approved for use in patients aged 5 years and older for treatment of acute uncomplicated influenza when symptoms have been present for no more than 48 hours, as well as for post-exposure prevention after contact with an infected person.
The approval was granted to Norwich Pharmaceuticals, Inc., for its abbreviated new drug application, according to the FDA. The agency said generic drugs approved by the FDA must meet the same quality and safety standards as their brand-name counterparts.
“Today’s approval marks a meaningful milestone for the treatment of influenza,” Iilun Murphy, M.D., director of the FDA’s Office of Generic Drugs within the Center for Drug Evaluation and Research, said in an FDA statement. Murphy said expanding access to medicines and improving ease of use are important public health goals, noting that influenza causes millions of illnesses in the United States each year.
Baloxavir marboxil works differently from older influenza antivirals by targeting an influenza virus enzyme involved in viral replication. The medicine is administered as a single oral dose, unlike some other antiviral treatments that require multiple doses over several days.
The FDA approval follows the original approval of Xofluza in 2018 and makes a generic option available for a treatment that regulators describe as the first single-dose influenza therapy of its type.
The agency said the drug carries warnings, including an increased incidence of treatment-emergent resistance in patients younger than 5 years old. The most commonly reported side effects include diarrhea, bronchitis, nausea, sinusitis and headache, according to FDA prescribing information.
Health officials continue to recommend influenza vaccination as a key measure to prevent seasonal flu, while antiviral medicines are used to treat infections or reduce the risk of illness after exposure in eligible patients.
The FDA said the approval was issued ahead of the upcoming flu season, with the generic product now authorized for distribution under its approved indications.
