The USFDA approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment for acute uncomplicated influenza and prophylaxis in patients 5 years of age and older, according to the agency.
The timing means the generic Xofluza will be available in time for the 2026–2027 flu season, the FDA says.
“Today’s approval marks a meaningful milestone for the treatment of influenza,” said Iilun Murphy, MD, 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 US 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.
The approval was granted to manufacturer Norwich Pharmaceuticals Inc. Xofluza is a registered trademark of Genentech Inc.
