Application Nr Approved Date Route Status External Links
ANDA204940 2015-11-27 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Omega-3-Acid Ethyl Esters Capsules Are Indicated As An Adjunct To Diet To Reduce Triglyceride (tg) Levels In Adult Patients With Severe (≥500 Mg/dl) Hypertriglyceridemia (htg). Usage Considerations: Patients Should Be Placed On An Appropriate Lipid-Lowering Diet Before Receiving Omega-3-Acid Ethyl Esters Capsules And Should Continue This Diet During Treatment With Omega-3-Acid Ethyl Esters Capsules. Laboratory Studies Should Be Done To Ascertain That The Lipid Levels Are Consistently Abnormal Before Instituting Therapy With Omega-3-Acid Ethyl Esters Capsules. Every Attempt Should Be Made To Control Serum Lipids With Appropriate Diet, Exercise, Weight Loss In Obese Patients, And Control Of Any Medical Problems Such As Diabetes Mellitus And Hypothyroidism That Are Contributing To The Lipid Abnormalities. Medications Known To Exacerbate Hypertriglyceridemia (such As Beta Blockers, Thiazides, Estrogens) Should Be Discontinued Or Changed If Possible Prior To Consideration Of Triglyceride-Lowering Drug Therapy. Limitations Of Use: The Effect Of Omega-3-Acid Ethyl Esters Capsules On The Risk For Pancreatitis Has Not Been Determined. The Effect Of Omega-3-Acid Ethyl Esters Capsules On Cardiovascular Mortality And Morbidity Has Not Been Determined. Omega-3-Acid Ethyl Esters Capsules Are A Combination Of Ethyl Esters Of Omega 3 Fatty Acids, Principally Epa And Dha, Indicated As An Adjunct To Diet To Reduce Triglyceride (tg) Levels In Adult Patients With Severe (≥500 Mg/dl) Hypertriglyceridemia (htg). (1) Limitations Of Use: The Effect Of Omega-3-Acid Ethyl Esters Capsules On The Risk For Pancreatitis Has Not Been Determined. (1) The Effect Of Omega-3-Acid Ethyl Esters Capsules On Cardiovascular Mortality And Morbidity Has Not Been Determined. (1)

All Formulated Excipients (2 Total)

Name Structure Kind Function Status
1. .alpha.-Tocopherol .ALPHA.-TOCOPHEROL Molecular
2. Gelatin GELATIN Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Omega-3-Acid Ethyl Esters

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