FDA approves first generic of Roche's flu drug Xofluza
The first generic alternative to Roche's oral drug for influenza, Xofluza, has been approved by the FDA and should be available in time for this year's flu season.
The Xofluza (baloxavir marboxil) generic, manufactured by Norwich Pharmaceuticals, has been given the go-ahead by the FDA as a single-dose treatment for acute uncomplicated influenza and prophylaxis in patients five years of age and older.
Xofluza was first approved in the US in 2018 as a treatment for acute uncomplicated influenza in patients aged 12 and over, with its label extended to include the prevention of flu after contact with an infected person in 2022, and the treatment of and prevention of flu in children aged five and over in 2022. Norwich's generic is approved for all those indications.
The drug – a follow-up to Roche's older antiviral Tamiflu (oseltamivir) – has achieved peak sales of more than $500 million a year, although revenues can fluctuate depending on the severity of the flu season. In the first quarter of 2026, for instance, sales fell more than 80% to around $24 million, mainly because the wave of infection started and finished earlier than usual. It is marketed in the US by Roche's Genentech subsidiary.
"Today's approval marks a meaningful milestone for the treatment of influenza," said Iilun Murphy, director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research (CDER).
"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 US each year," she added.
Seasonal influenza activity in the US is currently low, with overall respiratory illness levels well below epidemic thresholds. Nevertheless, during the 2025-2026 season, the CDC recorded around 32 million cases, 390,000 hospitalisations, and 24,000 deaths, including 179 in children.
The FDA also said that the approval "reflects the Trump administration's commitment to increasing the availability of generic drugs," which count for nine out of 10 prescriptions filled for medicines.
Last month, Roche signed a voluntary licence agreement with the Medicines Patent Pool (MPP) – an organisation that facilitates access to medicines in low- and middle-income countries (LMICs) – that will allow generic manufacturers to develop, produce and supply baloxavir in 129 countries.
The company said the licensing agreement "marks an important step towards strengthening global health security for future influenza outbreaks and pandemics."
Image by Mojca-Peter from Pixabay
