Treats acute uncomplicated influenza. NDA 210854, held by Genentech Inc. Baloxavir Marboxil.
As of Nov 14, 2026, NDA 210854 (Xofluza), held by Genentech Inc, was first approved by FDA on Oct 24, 2018, with 11 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 23Efficacy (new indication or use) · Standard review | Approved | |
| Dec 19, 2024 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Mar 1, 2024 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Aug 11, 2022 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Aug 11, 2022 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Nov 23, 2020 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Nov 23, 2020 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Oct 16, 2019 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Oct 24, 2018 | Original applicationNew molecular entity · Priority review | Approved |
| Xofluza20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Baloxavir Marboxil | DiscontinuedReference drug |
| Xofluza40MG · tablet;oral | Baloxavir Marboxil | RxReference drug |
| Xofluza80MG · tablet;oral | Baloxavir Marboxil | RxReference drug |
| May 30, 2025 | Supplement 23Efficacy (new indication or use) · Standard review | Approved | |
| Jan 29, 2025 | Supplement 24Manufacturing · Standard review | Approved | |
| Dec 19, 2024 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Mar 1, 2024 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Jun 15, 2023 | Supplement 18Labeling · Standard review | Approved | |
| Aug 11, 2022 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Aug 11, 2022 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Mar 18, 2021 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Nov 23, 2020 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Nov 23, 2020 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Oct 16, 2019 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Oct 24, 2018 | Original applicationNew molecular entity · Priority 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
