Regulatory PathRegulatory requirements compared

Active substance

Arformoterol

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLsolution · inhalationCIPLAPrescription22 Jun 2021
ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLsolution · inhalationADAPTISPrescription22 Jun 2021
ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLsolution · inhalationLUPINPrescription7 Feb 2022
ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLsolution · inhalationRITEDOSE CORPPrescription2 Mar 2022
ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLsolution · inhalationALEMBICPrescription10 May 2022
ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLsolution · inhalationSUN PHARMPrescription26 May 2022
ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLsolution · inhalationMANKIND PHARMAPrescription15 Nov 2022
ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLsolution · inhalationWILSHIRE PHARMS INCPrescription28 Nov 2022
ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLsolution · inhalationAIPING PHARM INCPrescription2 Apr 2024
ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLsolution · inhalationNEOCUBES PHARMAPrescription17 May 2024
ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLsolution · inhalationDR REDDYSPrescription3 Jun 2024
ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLsolution · inhalationLEXENPHARMPrescription18 Nov 2024
ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLsolution · inhalationAUCTAPrescription3 Feb 2025
ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLsolution · inhalationMICRO LABSPrescription7 Mar 2025
ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLsolution · inhalationSABA ILAC SANAYIPrescription25 Apr 2025
BROVANAEQ 0.015MG BASE/2MLsolution · inhalationLUPINDiscontinued6 Oct 2006
ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLsolution · inhalationGLENMARK PHARMS LTDDiscontinued22 Jun 2021
ARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLsolution · inhalationTEVA PHARMS USADiscontinued9 Nov 2021

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACARFORMOTEROL 15 MCG/2 ML SOLN$0.63275per ML23 Sep 2026
US NADACARFORMOTEROL 15 MCG/2 ML SOLN$0.6202per ML23 Sep 2026
US NADACBROVANA 15 MCG/2 ML SOLUTION$9.67343per ML22 Oct 2025
US NADACBROVANA 15 MCG/2 ML SOLUTION$9.74999per ML22 Oct 2025

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 29 May 2019 BROVANA — 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 arformoterol →

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.