Vazkepa Recordati Industria Chimica e Farmaceutica S.p.A. · Authorised · authorised 26 Mar 2021 · ATC C10AX
Therapeutic indication (EMA)
Indicated to reduce cardiovascular risk as an adjunct to statin therapy.
Active substance
Icosapent ethyl
- SFDA 1
- US FDA 13
- EMA 1
- Health Canada 1
- US price lines 3
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| VASCEPA 1GM CAPSULE | 1 g | Capsule, soft · Oral use | 120 Bottle | SAR 668.05 | NCE · Prescription | Amarin Pharmaceuticals Ireland Ltd | Valid |
Indications — CHI Daman Drug Formulary
DYSLIPIDEMIA
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| VASCEPA | 1GM; 500MG | capsule · oral | AMARIN PHARMS | Prescription | 26 Jul 2012 |
| ICOSAPENT ETHYL | 1GM; 500MG | capsule · oral | HIKMA PHARMS | Prescription | 21 May 2020 |
| ICOSAPENT ETHYL | 1GM; 500MG | capsule · oral | DR REDDYS | Prescription | 7 Aug 2020 |
| ICOSAPENT ETHYL | 500MG; 1GM | capsule · oral | TEVA PHARMS USA | Prescription | 11 Sep 2020 |
| ICOSAPENT ETHYL | 1GM | capsule · oral | APOTEX | Prescription | 30 Jun 2021 |
| ICOSAPENT ETHYL | 500MG; 1GM | capsule · oral | ZYDUS LIFESCIENCES | Prescription | 20 Apr 2023 |
| ICOSAPENT ETHYL | 500MG; 1GM | capsule · oral | ONESOURCE | Prescription | 22 Sep 2023 |
| ICOSAPENT ETHYL | 500MG; 1GM | capsule · oral | ASCENT PHARMS INC | Prescription | 7 Dec 2023 |
| ICOSAPENT ETHYL | 500MG; 1GM | capsule · oral | HUMANWELL PURACAP | Prescription | 22 Dec 2023 |
| ICOSAPENT ETHYL | 1GM | capsule · oral | QILU | Prescription | 20 Nov 2024 |
| ICOSAPENT ETHYL | 1GM | capsule · oral | TORRENT | Prescription | 20 Dec 2024 |
| ICOSAPENT ETHYL | 1GM | capsule · oral | XIAMEN LP PHARM CO | Prescription | 6 Aug 2025 |
| ICOSAPENT ETHYL | 1GM | capsule · oral | AUROBINDO PHARMA LTD | Prescription | 24 Jun 2026 |
EMA European Union — centrally authorised medicines
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| VASCEPA | 02495244 | 1 G | CAPSULE · ORAL | HLS THERAPEUTICS INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | ICOSAPENT ETHYL 0.5 GM CAPSULE | $0.33423 | per EA | 23 Sep 2026 |
| US NADAC | ICOSAPENT ETHYL 1 GRAM CAPSULE | $0.44081 | per EA | 23 Sep 2026 |
| US NADAC | ICOSAPENT ETHYL 500 MG CAPSULE | $0.33423 | 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.
Safety signals and safety-related labeling changes
- US FDA 13 Dec 2019 VASCEPA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
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.