Treats acute uncomplicated influenza. NDA 214410, held by Genentech Inc. Baloxavir Marboxil.
As of Nov 13, 2026, NDA 214410 (Xofluza), held by Genentech Inc, was first approved by FDA on Aug 11, 2022, with 5 approved supplements and 0 published complete response letters.
XOFLUZA is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated 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. Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza. Limitations of Use Influenza viruses change over time, and factors such as the virus type or subtype, emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs.
| May 30, 2025 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Dec 19, 2024 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Mar 1, 2024 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Aug 11, 2022 | Original applicationEfficacy (new indication or use) · Standard review | Approved | |
| Nov 23, 2020 | Original applicationNew dosage form · Standard review | Approved |
| Xofluza2MG/ML · for suspension;oral | Baloxavir Marboxil | RxReference drug |
| Xofluza30MG/PACKET · for suspension;oral | Baloxavir Marboxil | RxReference drug |
| Xofluza40MG/PACKET · for suspension;oral | Baloxavir Marboxil | RxReference drug |
| May 30, 2025 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Dec 19, 2024 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Mar 1, 2024 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Jun 15, 2023 | Supplement 5Labeling · Standard review | Approved | |
| Aug 11, 2022 | Original applicationEfficacy (new indication or use) · Standard review | Approved | |
| Sep 27, 2021 | Supplement 1Labeling · Standard review | Approved | |
| Nov 23, 2020 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
