MedPath

Fish oil

Generic Name
Fish oil
Brand Names
Omegaven
Drug Type
Biotech
Unique Ingredient Identifier
XGF7L72M0F

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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