Overview
Fish oil is a component of SMOFLIPID, which was FDA approved in July 2016. It is indicated in adults as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. More commonly, fish oil refers to the omega-3-fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) . In general, dietary or pharmaceutical intake of these acids is primarily the only way to increase their levels in the human body where they are overall an essential element to dietary health as they have demonstrated abilities in minimizing or preventing hypertriglyceridemia when taken as an adjunct to a healthy diet . Such fish oils are available in both non-prescription and prescription-only varieties at different concentrations. For many individuals, taking non-prescription fish oils as part of their multivitamin regimen is an effective way to supplement their diets with the healthy fatty acids. However, prescription-only fish oil products are sometimes prescribed for individuals who demonstrate severe (>= 500 mg/dL) hypertriglyceridemia . Furthermore, a variety of studies regarding additional potential actions of fish oil omega-3-fatty acids EPA and DHA are ongoing. Such experimental actions include inflammation modulation, cardioprotective effects, the attenuation of oxidative stress, and more. Regardless, the specific mechanisms of action for these effects have yet to be formally elucidated.
Indication
Under FDA approval, fish oil pharmaceuticals are typically products consisting of a combination of the omega-3-fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) and are indicated primarily as an adjunct to diet to reduce triglyceride levels in adult patients with severe (>=500 mg/dL) hypertriglyceridemia . Under EMA approval, such fish oil pharmaceuticals comprised of virtually the same fish and fish oil derived omega-3-fatty acids EPA and DHA are indicated specifically for (a) adjuvant treatment in secondary prevention after myocardial infarction, in addition to other standard therapy (ie. statins, antiplatelet medicinal products, beta blockers, ACE inhibitors), and (b) as a supplement to diet when dietary measures alone are insufficient to produce an adequate response, particularly with type IV hypertriglyceridemia in monotherapy or type IIb/III in combination with statins, when control of triglycerides is insufficient . In addition, prescribing information for EMA approved fish oil pharmaceuticals are also indicated as an adjunct to diet to reduce very high (>=500 mg/dL) triglyceride levels in adult patients, much like similar FDA approved indications .
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/02/28 | Phase 2 | Recruiting | |||
2024/02/23 | Phase 4 | Recruiting | |||
2022/11/14 | Phase 3 | Recruiting | |||
2021/07/16 | Not Applicable | Recruiting | |||
2021/03/19 | N/A | Withdrawn | |||
2021/01/06 | Phase 2 | Completed | Children's Mercy Hospital Kansas City | ||
2020/12/01 | Phase 2 | Completed | Karolinska University Hospital | ||
2020/07/10 | N/A | Completed | Stanley Dudrick's Memorial Hospital | ||
2020/05/13 | Phase 3 | UNKNOWN | |||
2019/08/28 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Fresenius Kabi USA, LLC | 63323-820 | INTRAVENOUS | 3 g in 100 mL | 8/30/2019 | |
Fresenius Kabi USA, LLC | 63323-205 | INTRAVENOUS | 0.1 g in 1 mL | 7/19/2023 |
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 |
---|---|---|---|---|---|
HAEMOCTIN SDH 250 FOR INJECTION 250 iu/vial | SIN10411P | INJECTION, POWDER, FOR SOLUTION | 250 iu/vial | 11/11/1998 | |
SmofKabiven Emulsion for Infusion | SIN14286P | INJECTION, EMULSION | 30g /1000ml | 1/8/2013 | |
SmofKabiven Peripheral Emulsion for Infusion | SIN14287P | INJECTION, EMULSION | 30g /1000ml | 1/8/2013 | |
SmofKabiven Electrolyte Free Emulsion for Infusion | SIN14292P | INJECTION, EMULSION | 30g /1000ml | 1/16/2013 | |
SMOFlipid 20% | SIN13246P | INJECTION, EMULSION | 30g per 1000ml | 4/12/2007 | |
SMOFKABIVEN EXTRA NITROGEN EMULSION FOR INFUSION | SIN16135P | INJECTION, EMULSION | 4.3g/1000ml | 3/24/2021 | |
SMOFKABIVEN EXTRA NITROGEN ELECTROLYTE-FREE EMULSION FOR INFUSION | SIN16136P | INJECTION, EMULSION | 4.3g/1000ml | 3/24/2021 |
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 |
---|---|---|---|---|---|
SMOFKABIVEN EMULSION FOR INFUSION | N/A | N/A | N/A | 5/26/2011 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
SMOFKABIVEN EXTRA NITROGEN ELECTROLYTE FREE | fresenius kabi canada ltd | 02501775 | Emulsion - Intravenous | 0.43 G / 100 ML | 7/9/2021 |
SMOFKABIVEN PERIPHERAL | fresenius kabi canada ltd | 02456206 | Emulsion - Intravenous | 420 MG / 100 ML | 2/14/2017 |
SMOFKABIVEN | fresenius kabi canada ltd | 02440695 | Emulsion - Intravenous | 0.57 G / 100 ML | 9/15/2015 |
SMOFLIPID 20% | fresenius kabi canada ltd | 02396963 | Emulsion - Intravenous | 3 % / W/V | 5/8/2013 |
SMOFKABIVEN EXTRA NITROGEN | fresenius kabi canada ltd | 02501813 | Emulsion - Intravenous | 0.43 G / 100 ML | 5/5/2021 |
SMOFKABIVEN ELECTROLYTE FREE | fresenius kabi canada ltd | 02440687 | Emulsion - Intravenous | 0.57 G / 100 ML | 9/15/2015 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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