Generic baloxavir marboxil approved for influenza

For Immediate Release: June 17, 2026

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, particularly given that influenza alone accounts for millions of illnesses in the U.S. each year.”

Generic baloxavir marboxil tablets may be used for:

• Treatment of 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

• Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza.

Baloxavir marboxil tablets are contraindicated in patients with a known history of hypersensitivity reactions to baloxavir marboxil or any of its ingredients. Baloxavir marboxil carries warnings such as increased incidence of treatment-emergent resistance in patients less than 5 years of age.

The most common side effects include diarrhea, bronchitis, nausea, sinusitis, and headaches. Healthcare providers should review the full prescribing information for complete safety and dosing information.

In the U.S., nine out of 10 prescriptions filled are for generic drugs. Increasing the availability of generic drugs helps to create competition in the marketplace, which then helps to make treatment more affordable and increases access to healthcare for more patients. Learn more about the FDA Drug Competition Action Plan.

Xofluza is a registered trademark of Genentech, Inc. FDA approved Norwich Pharmaceuticals, Inc.’s application for generic baloxavir marboxil tablets.

Related Information

Related Information

• Generic Drugs

• Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the “Orange Book”)

Media: FDA Request for Comment 202-690-6343

Consumer: 888-INFO-FDA

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.