Regulatory PathRegulatory requirements compared

Active substance

Formoterol

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
PERFOROMIST0.02MG/2MLsolution · inhalationVIATRIS SPECIALTYPrescription11 May 2007
FORMOTEROL FUMARATE0.02MG/2MLsolution · inhalationTEVA PHARMS USA INCPrescription22 Jun 2021
FORMOTEROL FUMARATE0.02MG/2MLsolution · inhalationALEMBICPrescription22 Nov 2021
FORMOTEROL FUMARATE0.02MG/2MLsolution · inhalationLUPINPrescription22 Aug 2022
FORMOTEROL FUMARATE0.02MG/2MLsolution · inhalationRITEDOSE CORPPrescription25 Nov 2022
FORMOTEROL FUMARATE0.02MG/2MLsolution · inhalationWILSHIRE PHARMS INCPrescription13 Dec 2022
FORMOTEROL FUMARATE0.02MG/2MLsolution · inhalationMANKIND PHARMAPrescription22 Mar 2023
FORMOTEROL FUMARATE0.02MG/2MLsolution · inhalationMICRO LABSPrescription26 Jun 2024
FORMOTEROL FUMARATE0.02MG/2MLsolution · inhalationLEXENPHARMPrescription22 Oct 2024
FORMOTEROL FUMARATE0.02MG/2MLsolution · inhalationDR REDDYSPrescription30 Jan 2025
FORMOTEROL FUMARATE0.02MG/2MLsolution · inhalationDEVA HOLDING ASPrescription11 Feb 2025
FORADIL0.012MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**powder · inhalationNOVARTISDiscontinued16 Feb 2001
FORADIL0.012MG/INHpowder · inhalationNOVARTISDiscontinued25 Sep 2001
FORADIL CERTIHALER0.0085MG/INHpowder · inhalationNOVARTISDiscontinued15 Dec 2006

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
OXEZE TURBUHALER0223722412 MCG / ACTPOWDER · INHALATIONASTRAZENECA CANADA INC
OXEZE TURBUHALER022372256 MCG / ACTPOWDER · INHALATIONASTRAZENECA CANADA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACFORMOTEROL 20 MCG/2 ML NEB VL$1.33557per ML23 Sep 2026
US NADACFORMOTEROL 20 MCG/2 ML NEB VL$1.27321per ML23 Sep 2026
US NADACPERFOROMIST 20 MCG/2 ML SOLN$10.04859per ML1 Jan 2026
US NADACPERFOROMIST 20 MCG/2 ML SOLN$10.1156per ML1 Jan 2026
NHS Drug TariffFormoterol 12micrograms/dose dry powder inhaler£24.8060 dose1 Oct 2026
NHS Drug TariffFormoterol 12micrograms/dose dry powder inhaler£23.75120 dose1 Oct 2026
NHS Drug TariffFormoterol 12micrograms/dose inhaler CFC free£30.06100 dose1 Oct 2026
NHS Drug TariffFormoterol 6micrograms/dose dry powder inhaler£24.8060 dose1 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 27 Apr 2026 BREZTRI AEROSPHERE — 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 27 Apr 2026 SYMBICORT AEROSPHERE — 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 5 Nov 2020 BEVESPI AEROSPHERE — 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 12 Aug 2019 DULERA — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 29 May 2019 PERFOROMIST — 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 20 Dec 2017 SYMBICORT — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for formoterol →

Combinations containing Formoterol

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.