FDA Approves Generic of Xofluza Tablets for First Time

The drug is meant for treatment of acute uncomplicated influenza.

June 18, 2026

Key Highlights

The FDA approved the first generic version of Xofluza, a single-dose flu treatment and prophylactic medication.
Suitable for patients aged 5 years and older, effective if taken within 48 hours of symptom onset.
Used for post-exposure prophylaxis following contact with an influenza-infected individual.
Contraindicated in patients with known hypersensitivity to baloxavir marboxil or its ingredients.
Common side effects include diarrhea, bronchitis, nausea, sinusitis, and headaches, with increased drug availability benefiting public health.

The FDA has approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment for acute uncomplicated influenza and prophylaxis.

The approval comes in time for the 2026-27 flu season. The tablets are to 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 "post-exposure prophylaxis of influenza...following contact with an individual who has influenza."

The medication is contraindicated in patients who have a "known history of hypersensitivity reactions to baloxavir marboxil or any of its ingredients." The most common side effects include diarrhea, bronchitis, nausea, sinusitis, and headaches.

This approval represents another step toward increasing the availability of generic drugs in the U.S.