The FDA has approved the first generic version of baloxavir marboxil (Xofluza), expanding access to a single-dose oral treatment and postexposure prophylaxis option for influenza in patients 5 years or older.
The US Food and Drug Administration (FDA) has approved the first generic version of baloxavir marboxil tablets, the active ingredient in the influenza antiviral Xofluza, providing patients with a more affordable single-dose treatment and prevention option ahead of the 2026-2027 influenza season.
The generic product, approved for use in patients 5 years or older, is indicated for the treatment of acute uncomplicated influenza in individuals who have been symptomatic for no more than 48 hours and are otherwise healthy or at high risk for influenza-related complications. It is also approved for postexposure prophylaxis following contact with a person infected with influenza.
“Today’s approval marks a meaningful milestone for the treatment of influenza,” Iilun Murphy, MD, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research, said in a statement. “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 US each year.”
The approval aligns with broader efforts to increase access to lower-cost generic medications. According to the FDA, generic drugs account for approximately 90% of prescriptions filled in the United States, helping to promote competition and reduce health care costs.
The approval marks the first generic version of Xofluza and the first generic single-dose oral influenza antiviral available for treatment and prevention.
Generic baloxavir marboxil is indicated for both acute uncomplicated influenza treatment and postexposure prophylaxis in patients 5 years or older.
Increased availability of generic baloxavir marboxil may improve patient access and affordability ahead of the 2026-2027 influenza season.
Baloxavir marboxil tablets are contraindicated in patients with a history of hypersensitivity reactions to the drug or its ingredients. Common adverse events include diarrhea, bronchitis, nausea, sinusitis, and headache. The drug also carries warnings regarding treatment-emergent resistance in younger pediatric populations.
The FDA approved the abbreviated new drug application submitted by Norwich Pharmaceuticals. The branded product, Xofluza, is a registered trademark of Genentech, Inc.
