Regulatory PathRegulatory requirements compared

Active substance

Lofexidine

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
LUCEMYRAEQ 0.18MG BASEtablet · oralBIOCORRX PHARMSPrescription16 May 2018
LOFEXIDINE HYDROCHLORIDEEQ 0.18MG BASEtablet · oralREGCON HOLDINGSPrescription20 Aug 2024
LOFEXIDINE HYDROCHLORIDEEQ 0.18MG BASEtablet · oralMSNPrescription24 Feb 2025
LOFEXIDINE HYDROCHLORIDEEQ 0.18MG BASEtablet · oralNOVITIUM PHARMAPrescription22 Oct 2025

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACLOFEXIDINE 0.18 MG TABLET$7.87932per EA23 Sep 2026
US NADACLUCEMYRA 0.18 MG TABLET$23.22082per EA19 Nov 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

All safety entries for lofexidine →

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.