Regulatory PathRegulatory requirements compared

Active substance

Tiagabine

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
GABITRIL4MG; 12MG; 16MG; 2MGtablet · oralCEPHALONPrescription30 Sep 1997
TIAGABINE HYDROCHLORIDE2MG; 4MG; 12MG; 16MGtablet · oralMSNPrescription16 Nov 2021
GABITRIL20MG; 6MG; 8MG; 10MGtablet · oralCEPHALONDiscontinued30 Sep 1997
TIAGABINE HYDROCHLORIDE2MG; 4MGtablet · oralSUN PHARM INDSDiscontinued4 Nov 2011
TIAGABINE HYDROCHLORIDE2MG; 4MG; 12MG; 16MGtablet · oralWILSHIRE PHARMS INCDiscontinued13 Oct 2017
TIAGABINE HYDROCHLORIDE2MG; 4MG; 12MG; 16MGtablet · oralAMNEAL PHARMS CODiscontinued8 Dec 2017

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACTIAGABINE HCL 12 MG TABLET$6.61904per EA23 Sep 2026
US NADACTIAGABINE HCL 2 MG TABLET$2.62176per EA23 Sep 2026
US NADACTIAGABINE HCL 4 MG TABLET$2.52464per EA23 Sep 2026
NHS Drug TariffTiagabine 10mg tablets£104.09100 tablet1 Oct 2026
NHS Drug TariffTiagabine 15mg tablets£156.13100 tablet1 Oct 2026
NHS Drug TariffTiagabine 5mg tablets£52.04100 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

All safety entries for tiagabine →

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.