Is Baloxavir marboxil approved by the US FDA?

Drugs@FDA lists 4 application product lines for Baloxavir marboxil, including XOFLUZA (Prescription); XOFLUZA (Prescription); BALOXAVIR MARBOXIL (Prescription); XOFLUZA (Discontinued).

Is Baloxavir marboxil authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Baloxavir marboxil: Xofluza.

Are there safety signals or safety updates for Baloxavir marboxil?

US FDA: 2 entries (latest 2025-05-30).

Active substance

Baloxavir marboxil

US FDA 4
EMA 1
Health Canada 3
US price lines 2
Safety 2

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
XOFLUZA	40MG; 80MG	tablet · oral	GENENTECH INC	Prescription	24 Oct 2018
XOFLUZA	2MG/ML; 30MG/PACKET; 40MG/PACKET	for suspension · oral	GENENTECH INC	Prescription	23 Nov 2020
BALOXAVIR MARBOXIL	40MG; 80MG	tablet · oral	NORWICH	Prescription	17 Jun 2026
XOFLUZA	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	GENENTECH INC	Discontinued	24 Oct 2018

EMA European Union — centrally authorised medicines

Xofluza Roche Registration GmbH · Authorised · authorised 7 Jan 2021

Therapeutic indication (EMA)

Treatment of influenza Xofluza is indicated for the treatment of uncomplicated influenza in patients aged 1 year and above. Post exposure prophylaxis of influenza Xofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 1 year and above. Xofluza should be used in accordance with official recommendations.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
XOFLUZA	02496364	20 MG	TABLET · ORAL	HOFFMANN-LA ROCHE LIMITED
XOFLUZA	02496372	40 MG	TABLET · ORAL	HOFFMANN-LA ROCHE LIMITED
XOFLUZA	02524163	80 MG	TABLET · ORAL	HOFFMANN-LA ROCHE LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	XOFLUZA 40 MG TABLET	$161.93879	per EA	23 Sep 2026
US NADAC	XOFLUZA 80 MG TABLET	$161.9469	per EA	23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 30 May 2025 XOFLUZA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 30 May 2025 XOFLUZA — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for baloxavir marboxil →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.