Is Ezetimibe + Simvastatin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 6 valid registrations of Ezetimibe + Simvastatin, including INEGY (20,10 mg,mg, Tablet, SAR 119.40); INEGY (40,10 mg,mg, Tablet, SAR 135.75); LUNIA (10,40 mg,mg, Tablet, SAR 156.55); LUNIA (10,20 mg,mg, Tablet, SAR 134.20); Simvagen Plus (10,20 mg,mg, Tablet, SAR 133.50).

Is Ezetimibe + Simvastatin approved by the US FDA?

Drugs@FDA lists 10 application product lines for Ezetimibe + Simvastatin, including VYTORIN (Prescription); EZETIMIBE AND SIMVASTATIN (Prescription); EZETIMIBE AND SIMVASTATIN (Prescription); EZETIMIBE AND SIMVASTATIN (Prescription); EZETIMIBE AND SIMVASTATIN (Prescription).

Active substances

Ezetimibe + Simvastatin

SFDA 9
US FDA 10
US price lines 6
NHS prices 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
INEGY	20,10 mg,mg	Tablet · Oral use	28 Blister	SAR 119.40	NCE · Prescription	Organon Pharma UK Limited	Valid
INEGY	40,10 mg,mg	Tablet · Oral use	28 Blister	SAR 135.75	NCE · Prescription	Organon Pharma UK Limited	Valid
LUNIA	10,40 mg,mg	Tablet · Oral use	28 Blister	SAR 156.55	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
LUNIA	10,20 mg,mg	Tablet · Oral use	28 Blister	SAR 134.20	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
Simvagen Plus	10,20 mg,mg	Tablet · Oral use	30 Blister	SAR 133.50	Generic · Prescription	RIYADH PHARMA	Valid
Simvagen Plus	10,40 mg,mg	Tablet · Oral use	30 Blister	SAR 155.75	Generic · Prescription	RIYADH PHARMA	Valid
INEGY 20-10MG TABLETS	20, 10 mg	Tablet · Oral use	28 Blister	SAR 273.40	NCE · Prescription	MERCK SHARP & DOHME	Withdrawn by MAH · Not Marketed
INEGY 40-10MG TABLET	40, 10 mg	Tablet · Oral use	28 Blister	SAR 296.70	NCE · Prescription	MERCK SHARP & DOHME	Withdrawn by MAH · Not Marketed
INEGY 80-10MG TABLETS	80, 10 mg	Tablet · Oral use	28 Blister	SAR 251.70	NCE · Prescription	MERCK SHARP & DOHME	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

CORONARY ARTERY DISEASE; DYSLIPIDEMIA

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

Product	Strength	Form · route	Applicant	Status	First approved
VYTORIN	10MG;10MG; 10MG;20MG; 10MG;40MG; 10MG;80MG	tablet · oral	ORGANON	Prescription	23 Jul 2004
EZETIMIBE AND SIMVASTATIN	10MG;10MG; 10MG;20MG; 10MG;40MG; 10MG;80MG	tablet · oral	DR REDDYS LABS SA	Prescription	26 Apr 2017
EZETIMIBE AND SIMVASTATIN	10MG;10MG; 10MG;20MG; 10MG;40MG; 10MG;80MG	tablet · oral	ALKEM LABS LTD	Prescription	22 Dec 2017
EZETIMIBE AND SIMVASTATIN	10MG;10MG; 10MG;20MG; 10MG;40MG; 10MG;80MG	tablet · oral	GLENMARK PHARMS LTD	Prescription	27 Jun 2019
EZETIMIBE AND SIMVASTATIN	10MG;10MG; 10MG;20MG; 10MG;40MG; 10MG;80MG	tablet · oral	AUROBINDO PHARMA USA	Prescription	17 Dec 2020
EZETIMIBE AND SIMVASTATIN	10MG;10MG; 10MG;20MG; 10MG;40MG; 10MG;80MG	tablet · oral	ANI PHARMS	Discontinued	26 Apr 2017
EZETIMIBE AND SIMVASTATIN	10MG;10MG; 10MG;20MG; 10MG;40MG; 10MG;80MG	tablet · oral	WATSON LABS INC	Discontinued	26 Apr 2017
EZETIMIBE AND SIMVASTATIN	10MG;10MG; 10MG;20MG; 10MG;40MG; 10MG;80MG	tablet · oral	AMNEAL PHARMS CO	Discontinued	21 Nov 2017
EZETIMIBE AND SIMVASTATIN	10MG;10MG; 10MG;20MG; 10MG;40MG; 10MG;80MG	tablet · oral	SCIEGEN PHARMS	Discontinued	10 Dec 2024
EZETIMIBE AND SIMVASTATIN	10MG;10MG; 10MG;20MG; 10MG;40MG; 10MG;80MG	tablet · oral	TORRENT	Discontinued	27 Jan 2025

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	EZETIMIBE-SIMVASTATIN 10-10 MG	$0.27376	per EA	23 Sep 2026
US NADAC	EZETIMIBE-SIMVASTATIN 10-20 MG	$0.1985	per EA	23 Sep 2026
US NADAC	EZETIMIBE-SIMVASTATIN 10-40 MG	$0.18305	per EA	23 Sep 2026
US NADAC	EZETIMIBE-SIMVASTATIN 10-80 MG	$0.28477	per EA	23 Sep 2026
US NADAC	VYTORIN 10-20 MG TABLET	$13.6206	per EA	23 Sep 2026
US NADAC	VYTORIN 10-40 MG TABLET	$13.79507	per EA	23 Sep 2026
NHS Drug Tariff	Simvastatin 20mg / Ezetimibe 10mg tablets	£33.42	28 tablet	1 Oct 2026
NHS Drug Tariff	Simvastatin 40mg / Ezetimibe 10mg tablets	£38.98	28 tablet	1 Oct 2026
NHS Drug Tariff	Simvastatin 80mg / Ezetimibe 10mg tablets	£41.21	28 tablet	1 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.

Components

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.