Regulatory PathRegulatory requirements compared

Active substance

Gabapentin enacarbil

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
HORIZANT600MG; 300MGtablet, extended release · oralAZURITYPrescription6 Apr 2011

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACHORIZANT ER 300 MG TABLET$17.92822per EA23 Sep 2026
US NADACHORIZANT ER 600 MG TABLET$17.90997per EA23 Sep 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 25 Apr 2025 HORIZANT — 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 gabapentin enacarbil →

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.