Regulatory PathRegulatory requirements compared

Active substance

Fesoterodine

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
TOVIAZ4MG; 8MGtablet, extended release · oralPFIZERPrescription31 Oct 2008
FESOTERODINE FUMARATE4MG; 8MGtablet, extended release · oralALKEM LABS LTDPrescription10 Dec 2015
FESOTERODINE FUMARATE4MG; 8MGtablet, extended release · oralAUROBINDO PHARMAPrescription17 Feb 2017
FESOTERODINE FUMARATE4MG; 8MGtablet, extended release · oralZYDUS PHARMSPrescription3 Oct 2017
FESOTERODINE FUMARATE4MG; 8MGtablet, extended release · oralDR REDDYSPrescription13 Aug 2019
FESOTERODINE FUMARATE4MG; 8MGtablet, extended release · oralALEMBICPrescription4 Jan 2023
FESOTERODINE FUMARATE4MG; 8MGtablet, extended release · oralAMNEAL PHARMS NYPrescription4 Jan 2023
FESOTERODINE FUMARATE4MG; 8MGtablet, extended release · oralHETERO LABS LTD VPrescription9 Jan 2024
FESOTERODINE FUMARATE4MG; 8MGtablet, extended release · oralANI PHARMSDiscontinued4 Jan 2023
FESOTERODINE FUMARATE4MG; 8MGtablet, extended release · oralACTAVIS LABS FL INCDiscontinued4 Jan 2023
FESOTERODINE FUMARATE4MG; 8MGtablet, extended release · oralACCORD HLTHCAREDiscontinued4 Jan 2023
FESOTERODINE FUMARATE4MG; 8MGtablet, extended release · oralCHARTWELL RXDiscontinued5 Jan 2023

EMA European Union — centrally authorised medicines

Toviaz Pfizer Europe MA EEIG · Authorised · authorised 20 Apr 2007 · ATC G04BD11

Therapeutic indication (EMA)

Treatment of the symptoms (increased urinary frequency and / or urgency and / or urgency incontinence) that may occur in patients with overactive-bladder syndrome.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ACH-FESOTERODINE025359984 MGTABLET (EXTENDED-RELEASE) · ORALACCORD HEALTHCARE INC
ACH-FESOTERODINE025360058 MGTABLET (EXTENDED-RELEASE) · ORALACCORD HEALTHCARE INC
SANDOZ FESOTERODINE FUMARATE025217684 MGTABLET (EXTENDED-RELEASE) · ORALSANDOZ CANADA INCORPORATED
SANDOZ FESOTERODINE FUMARATE025217768 MGTABLET (EXTENDED-RELEASE) · ORALSANDOZ CANADA INCORPORATED
TOVIAZ023800214 MGTABLET (EXTENDED-RELEASE) · ORALPFIZER CANADA ULC
TOVIAZ023800488 MGTABLET (EXTENDED-RELEASE) · ORALPFIZER CANADA ULC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACFESOTERODINE ER 4 MG TABLET$0.7938per EA23 Sep 2026
US NADACFESOTERODINE ER 8 MG TABLET$0.8393per EA23 Sep 2026
US NADACTOVIAZ ER 4 MG TABLET$9.27825per EA23 Sep 2026
US NADACTOVIAZ ER 8 MG TABLET$9.26235per EA23 Sep 2026
NHS Drug TariffFesoterodine 4mg modified-release tablets£8.1628 tablet1 Oct 2026
NHS Drug TariffFesoterodine 8mg modified-release tablets£8.2728 tablet1 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 28 Feb 2024 TOVIAZ — 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

All safety entries for fesoterodine →

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.