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."
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