Overview
Omega-3 fatty acids are polyunsaturated fatty acids (PUFAs) with a double bond at the third carbon atom from the end of the carbon chain. The three types of omega-3 fatty acids involved in human physiology are α-linolenic acid (ALA) (found in plant oils), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA) (both commonly found in fish oil that originally come from microalgae that is further consumed by phytoplankton, a source of diet for fish). Omega-3 fatty acids play a critical role in metabolism and cellular function and they are available as daily supplements. On September 8, 2004, the U.S. Food and Drug Administration gave "qualified health claim" status to EPA and DHA omega-3 fatty acids. Therapeutic products containing omega-3 fatty acid and its derivatives for treatment of hypertriglyceridemia include Lovaza, Omtryg, Epanova, and Vascepa.
Indication
Provided as daily supplements. Aa preparation of omega-3-acid ethyl esters is licensed in UK for prevention of recurrent events after myocardial infarction in addition to treatment of hypertriglyceridaemia.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/25 | Phase 2 | Not yet recruiting | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | ||
2024/06/18 | Not Applicable | Completed | |||
2024/05/30 | Phase 2 | Not yet recruiting | |||
2023/09/21 | N/A | Recruiting | |||
2023/03/20 | Phase 2 | Recruiting | |||
2022/01/28 | Phase 2 | Completed | Basma Morsy | ||
2021/11/16 | Phase 1 | Terminated | |||
2020/10/05 | Not Applicable | Active, not recruiting | |||
2020/08/19 | Phase 2 | Suspended | |||
2020/08/03 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Centurion Labs, LLC | 23359-105 | ORAL | 200 mg in 1 1 | 1/22/2024 | |
| Sterling-Knight Pharmaceuticals, LLC | 69336-349 | ORAL | 1220 mg in 1 1 | 1/17/2020 | |
| Everett Laboratories, Inc. | 0642-0092 | ORAL | 200 mg in 1 1 | 4/18/2012 | |
| Everett Laboratories, Inc. | 0642-0070 | ORAL | 200 mg in 1 1 | 9/1/2021 | |
| PBM Pharmaceuticals, Inc | 66213-543 | ORAL | 500 mg in 1 1 | 2/6/2013 | |
| Acella Pharmaceuticals, LLC | 42192-301 | ORAL | 500 mg in 1 1 | 10/11/2023 | |
| PBM Pharmaceuticals, Inc | 66213-542 | ORAL | 500 mg in 1 1 | 5/23/2011 | |
| Everett Laboratories, Inc. | 0642-3010 | ORAL | 200 mg in 1 1 | 11/28/2011 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| NUTRIFLEX® OMEGA SPECIAL B. BRAUN EMULSION FOR INFUSION | SIN16734P | INJECTION, EMULSION | 4.000g/1000ml | 3/7/2023 | |
| Lipidem 200mg/ml Emulsion for Infusion | SIN13614P | EMULSION | 20g/1000ml | 3/16/2009 | |
| NUTRIFLEX® OMEGA SPECIAL EMULSION FOR INFUSION | SIN15469P | INJECTION, EMULSION | 4.00g/1000ml | 4/23/2018 | |
| NUTRIFLEX® OMEGA PLUS EMULSION FOR INFUSION | SIN15468P | INJECTION, EMULSION | 4.00g/1000ml | 4/23/2018 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| NUTRIFLEX OMEGA SPECIAL EMULSION FOR INFUSION | N/A | N/A | N/A | 1/11/2012 | |
| NUTRIFLEX OMEGA PLUS EMULSION FOR INFUSION | N/A | N/A | N/A | 1/11/2012 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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