The U.S. Food and Drug Administration has approved the first generic version of Xofluza (baloxavir marboxil) tablets, marking the first single-dose generic treatment for acute uncomplicated influenza and influenza prevention in patients age 5 and older.

The approval comes ahead of the 2026-2027 flu season and, according to a news release from the FDA, reflects the Trump administration’s efforts to increase the availability of generic medications.

“Today’s approval marks a meaningful milestone for the treatment of influenza,” Iilun Murphy, M.D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research, said in the release. “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.”

Generic baloxavir marboxil tablets are approved for the treatment of acute uncomplicated influenza in patients 5 years and older who have experienced symptoms for no more than 48 hours and who are either otherwise healthy or at high risk of developing influenza-related complications.

The medication is also approved for post-exposure prophylaxis, or prevention, of influenza in patients 5 years and older following contact with someone who has the virus.

The FDA said baloxavir marboxil tablets are contraindicated for patients with a known history of hypersensitivity reactions to the drug or any of its ingredients. The medication also carries warnings, including an increased incidence of treatment-emergent resistance in patients younger than 5 years old.

The most common side effects reported with the drug include diarrhea, bronchitis, nausea, sinusitis and headaches. Healthcare providers are advised to review the full prescribing information for complete safety and dosing details.

According to the FDA, 90% of prescriptions filled in the United States are for generic drugs. The agency said expanding the availability of generics increases marketplace competition, helping make treatments more affordable and improving access to healthcare for more patients.

The approval was granted to Norwich Pharmaceuticals Inc. for its generic baloxavir marboxil tablets. Xofluza is a registered trademark of Genentech Inc.

The FDA also encouraged the public to learn more about its Drug Competition Action Plan, which is aimed at increasing competition and access within the pharmaceutical market.