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Medical Daily
Medical Daily
Cole Mercer

FDA Approves First Generic Baloxavir (Xofluza): Single-Dose Flu Treatment Now Available at Generic Price

The Food and Drug Administration approved the first generic version of Xofluza on June 17, 2026 — giving patients ages 5 and older access to the most convenient flu treatment available at a price that marketplace competition is expected to significantly reduce.

"Today's approval marks a meaningful milestone for the treatment of influenza," said Iilun Murphy, M.D., 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."

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