Active substance
Fluvastatin
- SFDA 3
- US FDA 7
- Health Canada 2
- US price lines 4
- NHS prices 3
- WHO EML 1
- Safety 7
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| LESCOL XL 80 MG FILM COATED TAB | 80 mg | Prolonged-release tablet · Oral use | 28 Blister | SAR 51.50 | NCE · Prescription | ETHYX PHARMACEUTICALS | Valid |
| LESCOL 40MG CAPS | 40 mg | Capsule · Oral use | 28 Blister | SAR 94.80 | NCE · Prescription | NOVARTIS | Withdrawn by MAH · Not Marketed |
| LESCOL XL 80 MG FILM COATED TAB | 80 mg | Prolonged-release tablet · Oral use | 28 Blister | SAR 118.80 | NCE · Prescription | NOVARTIS | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ANTIPHOSPHOLIPID SYNDROME; CORONARY ARTERY DISEASE; DYSLIPIDEMIA; NON-ST WAVE ELEVATED MYOCARDIAL INFARCTION (NSTEMI); ST-WAVE ELEVATED MYOCARDIAL INFARCTION (STEMI)
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| LESCOL XL | EQ 80MG BASE | tablet, extended release · oral | SANDOZ | Prescription | 6 Oct 2000 |
| FLUVASTATIN SODIUM | EQ 20MG BASE; EQ 40MG BASE | capsule · oral | MYLAN PHARMS INC | Prescription | 11 Apr 2012 |
| FLUVASTATIN SODIUM | EQ 20MG BASE; EQ 40MG BASE | capsule · oral | TEVA PHARMS | Prescription | 12 Jun 2012 |
| FLUVASTATIN SODIUM | EQ 80MG BASE | tablet, extended release · oral | TEVA PHARMS USA | Prescription | 27 Jan 2016 |
| FLUVASTATIN SODIUM | EQ 80MG BASE | tablet, extended release · oral | BEIJING | Prescription | 26 Apr 2021 |
| LESCOL | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | capsule · oral | NOVARTIS | Discontinued | 31 Dec 1993 |
| FLUVASTATIN SODIUM | EQ 80MG BASE | tablet, extended release · oral | PHARMOBEDIENT | Discontinued | 11 Sep 2015 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| TEVA-FLUVASTATIN | 02299224 | 20 MG | CAPSULE · ORAL | TEVA CANADA LIMITED |
| TEVA-FLUVASTATIN | 02299232 | 40 MG | CAPSULE · ORAL | TEVA CANADA LIMITED |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | FLUVASTATIN ER 80 MG TABLET | $2.87934 | per EA | 23 Sep 2026 |
| US NADAC | FLUVASTATIN SODIUM 20 MG CAP | $2.67293 | per EA | 23 Sep 2026 |
| US NADAC | FLUVASTATIN SODIUM 40 MG CAP | $2.86261 | per EA | 23 Sep 2026 |
| US NADAC | LESCOL XL 80 MG TABLET | $13.06433 | per EA | 18 Feb 2026 |
| NHS Drug Tariff | Fluvastatin 20mg capsules | £3.45 | 28 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Fluvastatin 40mg capsules | £8.08 | 28 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Fluvastatin 80mg modified-release tablets | £19.20 | 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.
WHO WHO Model List of Essential Medicines (2025)
- 12.6. Lipid-lowering agents · core
Therapeutic equivalent to simvastatin for Mixed hyperlipidaemia; Therapeutic equivalent to simvastatin for Coronary atherosclerosis
Safety signals and safety-related labeling changes
- US FDA 28 Nov 2023 LESCOL XL — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 13 Jan 2023 PRAC signal: Myasthenia gravis
Action for MAH: update of the product information: Yes - EMA PRAC 7 Jul 2022 PRAC signal: Myasthenia gravis
Action for MAH: update of the product information: No - EMA PRAC 11 Feb 2021 PRAC signal: Bullous pemphigoid
Action for MAH: update of the product information: No - EMA PRAC 3 Sep 2020 PRAC signal: Bullous pemphigoid
Action for MAH: update of the product information: No - US FDA 4 Aug 2017 LESCOL — safety-related labeling change
Labeling sections changed: Adverse Reactions - EMA PRAC 11 Jun 2015 PRAC signal: Lichenoid drug eruption
Action for MAH: update of the product information: No
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.