FDA Approves First Single-Dose Generic Flu Treatment: Baloxavir Marboxil Tablets for Patients 5 and Older
The U.S. Food and Drug Administration (FDA) on June 17 approved the first generic version of Xofluza (baloxavir marboxil tablets), the first single-dose treatment for acute uncomplicated influenza and for post-exposure prophylaxis in patients 5 years of age and older. The FDA said the approval came in time for the 2026-2027 flu season.
The generic baloxavir marboxil tablets may be used to treat acute uncomplicated influenza in patients 5 years of age and older 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 for post-exposure prophylaxis in patients 5 years of age and older following contact with an individual who has influenza.
"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 the 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."
The FDA said baloxavir marboxil tablets are contraindicated in patients with a known history of hypersensitivity reactions to baloxavir marboxil or any of its ingredients, and that the drug carries warnings including an increased incidence of treatment-emergent resistance in patients under 5 years of age. The most common side effects include diarrhea, bronchitis, nausea, sinusitis and headaches, and healthcare providers should review the full prescribing information.
The FDA noted that nine out of 10 prescriptions filled in the U.S. are for generic drugs, and that increasing their availability helps create competition, make treatment more affordable and increase access to healthcare. Xofluza is a registered trademark of Genentech, Inc.; the approved generic application was submitted by Norwich Pharmaceuticals, Inc. (According to the FDA news release on its official website)
Source: GSM · USA (original Chinese edition)
Photo: 图：美国食品药品监督管理局（FDA）总部 White Oak 园区大楼。FDA 官方照片，公共领域。 / Photo: FDA headquarters building at the White Oak campus. U.S. Food and Drug Administration photo, public domain.
