FDA Approves First Single-Dose Generic Treatment for Influenza

The U.S. Food and Drug Administration today 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, this approval reflects the Trump Administration’s commitment to increasing the availability of generic drugs.“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, particular...