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# Roche Xofluza OK for Acute Uncomplicated Flu
- URL: https://www.fdaweb.com/roche-xofluza-ok-for-acute-uncomplicated-flu/
- Published: 2022-08-12T12:00:00.000Z
- Updated: 2026-09-14T17:55:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152500

FDA has approved a Roche a supplemental NDA for Xofluza (baloxavir marboxil) for treating acute uncomplicated influenza in children aged five to less than 12 years of age who have been symptomatic for no more than 48 hours. Additionally, the agency approved Xofluza for preventing (post-exposure prophylaxis) influenza in this same age group.

Approval was based on data from two Phase 3 studies: miniSTONE-2, which evaluated the use of Xofluza in children, and BLOCKSTONE, which evaluated Xofluza as a preventive treatment for household members, in both adults and children.

Xofluza was previously approved for treating influenza in people 12 years of age and older who have had influenza symptoms for no more than 48 hours. And it was approved for preventing influenza in people 12 years of age and older following contact with someone with influenza.