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Generic Single-Dose Flu Antiviral Gets FDA's Blessing
The approval is meant to boost competition and affordability, with the FDA saying generics fill 9 out of 10 U.S. prescriptions.
- On Wednesday, the U.S. Food and Drug Administration approved the first generic version of Xofluza , manufactured by Norwich Pharmaceuticals, as a single-dose treatment for acute uncomplicated influenza in patients five years and older.
- The FDA stated the approval reflects the Trump Administration's commitment to increasing generic drug availability; generics currently account for nine out of 10 prescriptions filled in the U.S.
- Unlike other antiviral medications requiring twice-daily doses for five days, baloxavir is taken as a single dose, potentially improving treatment completion rates and affordability for patients.
- "Today's approval marks a meaningful milestone for the treatment of influenza," said Iilun Murphy, director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research .
- Vaccination remains the best way to reduce severe influenza risk; health experts emphasize this generic is a treatment, not a substitute for preventative shots.
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Generic Single-Dose Flu Antiviral Gets FDA's Blessing
(MedPage Today) -- The FDA this week approved the first generic version of baloxavir marboxil (Xofluza) as a single-dose option to treat or prevent influenza in adults and children 5 years and up. In the treatment setting, the single-dose tablet...
·New York, United States
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FDA Approves First Generic Xofluza for Flu Treatment
FRANKFORT – The U.S. Food and Drug Administration (FDA) 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. Approved in time for the 2026–2027 flu season, the FDA says this approval reflects the Trump Administration’s commitment to increasing the availability of generic drugs. “This approval marks a meaningf…
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