Regulatory PathRegulatory requirements compared

Active substance

Pimozide

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ORAP FORTE TAB 4 MG4 mgTablet · Oral use20 BlisterSAR 27.95NCE · PrescriptionJANSSEN PHARMACEUTICA N.VWithdrawn by MAH · Not Marketed

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

ProductStrengthForm · routeApplicantStatusFirst approved
PIMOZIDE1MG; 2MGtablet · oralPH HEALTHPrescription28 Sep 2015
PIMOZIDE1MG; 2MGtablet · oralNOVITIUM PHARMAPrescription13 Apr 2026
ORAP2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralTEVADiscontinued31 Jul 1984

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
PIMOZIDE022454322 MGTABLET · ORALAA PHARMA INC
PIMOZIDE022454334 MGTABLET · ORALAA PHARMA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACPIMOZIDE 1 MG TABLET$1.23492per EA23 Sep 2026
US NADACPIMOZIDE 2 MG TABLET$1.63995per EA23 Sep 2026
NHS Drug TariffPimozide 4mg tablets£40.31100 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.

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.