Is Indacaterol approved by the US FDA?

Drugs@FDA lists 1 application product line for Indacaterol, including ARCAPTA NEOHALER (Discontinued).

Is Indacaterol authorised in the European Union?

EMA lists 3 centrally authorised medicines containing Indacaterol: Onbrez Breezhaler, Oslif Breezhaler, Hirobriz Breezhaler.

Are there safety signals or safety updates for Indacaterol?

US FDA: 2 entries (latest 2021-07-30).

Active substance

Indacaterol

US FDA 1
EMA 3
NHS prices 2
Safety 2

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
ARCAPTA NEOHALER	EQ 75MCG BASE	powder · inhalation	NOVARTIS	Discontinued	1 Jul 2011

EMA European Union — centrally authorised medicines

Onbrez Breezhaler Novartis Europharm Limited · Authorised · authorised 29 Nov 2009 · ATC R03AC18

Therapeutic indication (EMA)

Onbrez Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.

Oslif Breezhaler Novartis Europharm Limited · Authorised · authorised 29 Nov 2009 · ATC R03AC18

Therapeutic indication (EMA)

Oslif Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.

Hirobriz Breezhaler Novartis Europharm Limited · Authorised · authorised 30 Nov 2009 · ATC R03AC18

Therapeutic indication (EMA)

Hirobriz Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
NHS Drug Tariff	Indacaterol 150microgram inhalation powder capsules with device	£32.19	30 capsule	1 Oct 2026
NHS Drug Tariff	Indacaterol 300microgram inhalation powder capsules with device	£32.19	30 capsule	1 Oct 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 Jul 2021 ARCAPTA NEOHALER — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 30 Jul 2021 UTIBRON — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for indacaterol →

Combinations containing Indacaterol

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.