Active substance
Omega 3 acid ethyl esters
- SFDA 2
- US FDA 16
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| OMEGANA 1000MG SOFT CAPSULE | 1000 mg | Capsule · Oral use | 28 Bottle | SAR 48.95 | Generic · OTC | VIANEX S.A | Valid |
| OMEGANA 1000MG SOFT CAPSULE | 1000 mg | Capsule · Oral use | 100 Bottle | SAR 174.80 | Generic · OTC | VIANEX S.A | Valid |
Indications — CHI Daman Drug Formulary
ACUTE BIPOLAR I DEPRESSION; CONGESTIVE HEART FAILURE; DYSLIPIDEMIA
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | capsule · oral | WAYLIS THERAP | Prescription | 10 Nov 2004 |
| OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | capsule · oral | RENOVA PHARMS | Prescription | 7 Apr 2014 |
| OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | capsule · oral | ONESOURCE | Prescription | 19 Sep 2017 |
| OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | capsule · oral | ASCENT PHARMS INC | Prescription | 25 Feb 2019 |
| OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | capsule · oral | CHARTWELL | Prescription | 7 Aug 2019 |
| OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | capsule · oral | CSPC-NBP PHARM | Prescription | 12 May 2020 |
| OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | capsule · oral | PURACAP PHARM LLC | Prescription | 15 Jun 2020 |
| OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | capsule · oral | PHARMOBEDIENT | Prescription | 19 Aug 2020 |
| OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | capsule · oral | MANKIND PHARMA | Prescription | 15 Nov 2021 |
| OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | capsule · oral | WILSHIRE PHARMS INC | Prescription | 7 Dec 2023 |
| OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | capsule · oral | ONESOURCE | Discontinued | 24 Jun 2014 |
| OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | capsule · oral | APOTEX | Discontinued | 30 Sep 2014 |
| OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | capsule · oral | AMNEAL PHARMS | Discontinued | 27 Nov 2015 |
| OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | capsule · oral | ZYDUS LIFESCIENCES | Discontinued | 14 Jun 2019 |
| OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | capsule · oral | SOFGEN PHARMS | Discontinued | 10 Jul 2019 |
| OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | capsule · oral | SUN PHARM | Discontinued | 9 Jan 2020 |
Safety signals and safety-related labeling changes
- US FDA 4 Sep 2020 LOVAZA — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations
Combinations containing Omega 3 acid ethyl esters
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.