Active substance
Lovastatin
- US FDA 12
- Health Canada 2
- US price lines 3
- WHO EML 1
- Safety 6
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| LOVASTATIN | 10MG; 20MG; 40MG | tablet · oral | CHARTWELL RX | Prescription | 17 Dec 2001 |
| LOVASTATIN | 40MG; 20MG; 10MG | tablet · oral | TEVA | Prescription | 17 Dec 2001 |
| LOVASTATIN | 10MG; 20MG; 40MG | tablet · oral | EPIC PHARMA LLC | Prescription | 17 Dec 2001 |
| LOVASTATIN | 10MG; 20MG; 40MG | tablet · oral | ACTAVIS ELIZABETH | Prescription | 17 Dec 2001 |
| LOVASTATIN | 10MG; 20MG; 40MG | tablet · oral | CARLSBAD | Prescription | 5 Jun 2002 |
| LOVASTATIN | 10MG; 20MG; 40MG | tablet · oral | COREPHARMA | Prescription | 28 Feb 2007 |
| LOVASTATIN | 10MG; 20MG; 40MG | tablet · oral | LUPIN | Prescription | 1 Nov 2007 |
| MEVACOR | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 20MG **Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons**; 40MG **Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | MERCK | Discontinued | 31 Aug 1987 |
| LOVASTATIN | 10MG; 20MG; 40MG | tablet · oral | AUROBINDO PHARMA USA | Discontinued | 17 Dec 2001 |
| LOVASTATIN | 10MG; 20MG; 40MG | tablet · oral | AUROBINDO PHARMA USA | Discontinued | 17 Dec 2001 |
| ALTOPREV | 10MG; 20MG; 40MG; 60MG | tablet, extended release · oral | AZURITY | Discontinued | 26 Jun 2002 |
| LOVASTATIN | 10MG; 20MG; 40MG | tablet · oral | SUN PHARM INDUSTRIES | Discontinued | 14 Apr 2006 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| LOVASTATIN | 02220172 | 20 MG | TABLET · ORAL | AA PHARMA INC |
| LOVASTATIN | 02220180 | 40 MG | TABLET · ORAL | AA PHARMA INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | LOVASTATIN 10 MG TABLET | $0.03653 | per EA | 23 Sep 2026 |
| US NADAC | LOVASTATIN 20 MG TABLET | $0.04357 | per EA | 23 Sep 2026 |
| US NADAC | LOVASTATIN 40 MG TABLET | $0.0552 | per EA | 23 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.
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 14 Mar 2024 ALTOPREV — 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 - 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.