WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration has 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. This approval is to increase the availability of generic drugs in time for the 2026-2027 flu season, FDA said.
'Today's approval marks a meaningful milestone for the treatment of influenza,' said Iilun Murphy, 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 U.S. each year.'
Generic baloxavir marboxil tablets may be used to treat acute uncomplicated influenza in patients above 5 years, 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 sme one who has influenza.
Baloxavir marboxil tablets are contraindicated in patients with a history of hypersensitivity reactions to baloxavir marboxil or any of its ingredients. The medicine carries warnings such as increased incidence of treatment-emergent resistance in patients below 5 years.
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.
Xofluza is a registered trademark of Genentech, Inc. FDA approved Norwich Pharmaceuticals' application for generic baloxavir marboxil tablets.
In the U.S., nine out of 10 prescriptions filled are for generic drugs, according to FDA.
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