Regulatory PathRegulatory requirements compared

Active substance

Valbenazine

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
INGREZZAEQ 40MG BASE; EQ 80MG BASE; EQ 60MG BASEcapsule · oralNEUROCRINEPrescription11 Apr 2017
VALBENAZINE TOSYLATEEQ 40MG BASE; EQ 80MG BASE; EQ 60MG BASEcapsule · oralLUPINPrescription5 Apr 2024
INGREZZA SPRINKLEEQ 40MG BASE; EQ 60MG BASE; EQ 80MG BASEcapsule · oralNEUROCRINEPrescription30 Apr 2024
VALBENAZINE TOSYLATEEQ 40MG BASE; EQ 60MG BASE; EQ 80MG BASEcapsule · oralZYDUS LIFESCIENCESDiscontinued7 Aug 2024

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACINGREZZA 40 MG CAPSULE$258.94167per EA23 Sep 2026
US NADACINGREZZA 60 MG CAPSULE$283.324per EA23 Sep 2026
US NADACINGREZZA 80 MG CAPSULE$283.324per 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 4 Feb 2025 INGREZZA — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for valbenazine →

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.