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Treats acute uncomplicated influenza. Sold as Xofluza. Every FDA application for this active ingredient: 2 branded and 1 generic.
As of Nov 15, 2026, FDA lists 3 applications for Baloxavir Marboxil (sold as Xofluza), first approved Oct 24, 2018, with 11 new uses approved and 0 published complete response letters.
First approved: Oct 24, 2018
Applications: 3
New uses approved: 11
Complete response letters: 0
Medicare spending, 2025: $3.0M
First approved in the EU: Jan 7, 2021
First approved in Japan: Feb 23, 2018
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Product
Part
Spending, 2025
Change
Beneficiaries
Xofluza
Part D
$3.0M
+142%
17,376
What Pharmacies Pay
Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change
XOFLUZA 40 MG TABLET: $161.90 per unitBrand · 0% in a year
XOFLUZA 80 MG TABLET: $161.90 per unitBrand · 0% in a year
Approvals in the EU (EMA)
First approved in the EU 26 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals
First approved in Japan 8 months before the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
XofluzaA drug with a new additional pediatric dosage indicated for the treatment of influenza A or B virus infection. · Shionogi & Co., Ltd. · Sep 19, 2025
XofluzaDrugs with a new indication and a new dosage for the prophylaxis of influenza A or B virus infection. · Shionogi & Co., Ltd. · Nov 27, 2020 · Review report
Xofluza, new ingredientDrugs with a new active ingredient indicated for the treatment of influenza A or B virus infections. · Shionogi & Co., Ltd. · Feb 23, 2018 · Review report
Clinical Trials
9 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
