FDA Approves First Generic Version of Roche's Single-Dose Influenza Antiviral Xofluza
On June 18, 2026, the U.S. Food and Drug Administration (FDA) approved the first generic version of Genentech/Roche's Xofluza (baloxavir marboxil) tablets. The landmark approval, granted to Norwich Pharmaceuticals, Inc., introduces a generic single-dose oral antiviral option for both the treatment of acute uncomplicated influenza and post-exposure prophylaxis in patients aged 5 years and older.
Baloxavir marboxil is a first-in-class, cap-dependent endonuclease inhibitor that works by inhibiting viral replication early in the viral life cycle. Unlike traditional multi-day influenza treatments such as oseltamivir (Tamiflu), baloxavir marboxil requires only a single oral dose, which significantly enhances patient compliance and ease of use. The approval is timed strategically ahead of the 2026–2027 flu season to expand access to affordable, single-dose therapies.
The generic tablets carry the same indications, warnings, and precautions as the brand-name drug, including a warning against use in children under 5 years of age due to an increased incidence of treatment-emergent resistance. The most common side effects observed in clinical trials include diarrhea, bronchitis, nausea, sinusitis, and headache.
"Today’s approval marks a meaningful milestone for the treatment of influenza. 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." — Dr. Iilun Murphy, Director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research (CDER) in the FDA GlobeNewswire Release