Is Ranolazine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Ranolazine, including Ranexa (375 mg, Prolonged-release tablet, SAR 114.20); Ranexa (500 mg, Prolonged-release tablet, SAR 114.20); Ranexa (750 mg, Prolonged-release tablet, SAR 114.20).

Is Ranolazine approved by the US FDA?

Drugs@FDA lists 29 application product lines for Ranolazine, including RANOLAZINE (Prescription); RANOLAZINE (Prescription); RANOLAZINE (Prescription); RANOLAZINE (Prescription); RANOLAZINE (Prescription).

Is Ranolazine authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Ranolazine: Ranexa (previously Latixa).

Are there safety signals or safety updates for Ranolazine?

US FDA: 1 entry (latest 2019-08-07).

Active substance

Ranolazine

SFDA 3
US FDA 29
EMA 1
Health Canada 3
US price lines 2
NHS prices 3
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Ranexa	375 mg	Prolonged-release tablet · Oral use	60 Blister	SAR 114.20	NCE · Prescription	Menarini International O. L. S.A	Valid
Ranexa	500 mg	Prolonged-release tablet · Oral use	60 Blister	SAR 114.20	NCE · Prescription	Menarini International O. L. S.A	Valid
Ranexa	750 mg	Prolonged-release tablet · Oral use	60 Blister	SAR 114.20	NCE · Prescription	Menarini International O. L. S.A	Valid

Indications — CHI Daman Drug Formulary

CORONARY ARTERY DISEASE

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

Product	Strength	Form · route	Applicant	Status	First approved
RANOLAZINE	500MG; 1GM	tablet, extended release · oral	CHARTWELL RX	Prescription	29 Jul 2013
RANOLAZINE	500MG; 1GM	tablet, extended release · oral	AJANTA PHARMA LTD	Prescription	28 May 2019
RANOLAZINE	500MG; 1GM	tablet, extended release · oral	SCIEGEN PHARMS	Prescription	4 Jun 2019
RANOLAZINE	500MG; 1GM	tablet, extended release · oral	GLENMARK PHARMS LTD	Prescription	5 Jul 2019
RANOLAZINE	500MG; 1GM	tablet, extended release · oral	CADILA	Prescription	19 Aug 2019
RANOLAZINE	500MG; 1GM	tablet, extended release · oral	MANKIND PHARMA	Prescription	12 Feb 2020
RANOLAZINE	500MG; 1GM	tablet, extended release · oral	SUNSHINE	Prescription	23 Mar 2020
RANOLAZINE	500MG; 1GM	tablet, extended release · oral	QUAGEN	Prescription	23 Mar 2020
RANOLAZINE	500MG; 1GM	tablet, extended release · oral	ALKEM LABS LTD	Prescription	30 Nov 2020
RANOLAZINE	500MG; 1GM	tablet, extended release · oral	RISING	Prescription	28 Jan 2021
RANOLAZINE	500MG; 1GM	tablet, extended release · oral	VKT PHARMA	Prescription	19 Jan 2022
RANOLAZINE	500MG; 1GM	tablet, extended release · oral	PHARMAZONE	Prescription	27 Apr 2022
RANOLAZINE	500MG; 1GM	tablet, extended release · oral	HETERO LABS LTD III	Prescription	5 May 2022
RANOLAZINE	500MG; 1GM	tablet, extended release · oral	AUROBINDO PHARMA	Prescription	23 Dec 2022
RANOLAZINE	500MG; 1GM	tablet, extended release · oral	UNICHEM	Prescription	16 Mar 2023
RANOLAZINE	500MG; 1GM	tablet, extended release · oral	PIRAMAL	Prescription	25 Jul 2023
RANOLAZINE	500MG; 1GM	tablet, extended release · oral	NOVAST LABS	Prescription	27 Sep 2023
RANOLAZINE	500MG; 1GM	tablet, extended release · oral	JUBILANT GENERICS	Prescription	15 Apr 2025
RANOLAZINE	500MG; 1GM	tablet, extended release · oral	UMEDICA	Prescription	5 Aug 2026
RANEXA	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet, extended release · oral	MENARINI INTL	Discontinued	27 Jan 2006
RANOLAZINE	500MG; 1GM	tablet, extended release · oral	ACTAVIS ELIZABETH	Discontinued	28 May 2019
RANOLAZINE	500MG; 1GM	tablet, extended release · oral	CIPLA	Discontinued	28 May 2019
RANOLAZINE	500MG; 1GM	tablet, extended release · oral	SUN PHARM	Discontinued	28 May 2019
RANOLAZINE	500MG; 1GM	tablet, extended release · oral	ANI PHARMS	Discontinued	29 Oct 2019
RANOLAZINE	500MG; 1GM	tablet, extended release · oral	MICRO LABS	Discontinued	27 Feb 2020

4 more — full table

EMA European Union — centrally authorised medicines

Ranexa (previously Latixa) Menarini International Operations Luxembourg S.A. (MIOL) · Authorised · authorised 8 Jul 2008 · ATC C01EB18

Therapeutic indication (EMA)

Ranexa is indicated as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line anti-anginal therapies (such as beta-blockers and / or calcium antagonists).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CORZYNA	02510219	500 MG	TABLET (EXTENDED-RELEASE) · ORAL	KYE PHARMACEUTICALS INC.
CORZYNA	02510227	1000 MG	TABLET (EXTENDED-RELEASE) · ORAL	KYE PHARMACEUTICALS INC.
MAR-RANOLAZINE XR	02562448	500 MG	TABLET (EXTENDED-RELEASE) · ORAL	MARCAN PHARMACEUTICALS INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	RANOLAZINE ER 1,000 MG TABLET	$0.27428	per EA	23 Sep 2026
US NADAC	RANOLAZINE ER 500 MG TABLET	$0.16493	per EA	23 Sep 2026
NHS Drug Tariff	Ranolazine 375mg modified-release tablets	£6.31	60 tablet	1 Oct 2026
NHS Drug Tariff	Ranolazine 500mg modified-release tablets	£6.47	60 tablet	1 Oct 2026
NHS Drug Tariff	Ranolazine 750mg modified-release tablets	£9.89	60 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.

Safety signals and safety-related labeling changes

US FDA 7 Aug 2019 RANEXA — safety-related labeling change
Labeling sections changed: Adverse Reactions

All safety entries for ranolazine →

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.