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Generic Name: omega-3-acid ethyl esters

Summary for Generic Name: omega-3-acid ethyl esters

Tradenames:1
Patents:3
Applicants:1
NDAs:1
Drug Master File Entries: see list9
Suppliers: see list5
Therapeutic Class:Cardiovascular Agents

Pharmacology for Ingredient: omega-3-acid ethyl esters

Ingredient-typeFatty Acids, Omega-3
Drug ClassOmega-3 Fatty Acid

Clinical Trials for: omega-3-acid ethyl esters

Evaluation of Efficacy and Safety of Omacor (Omega-3-acid Ethyl Esters) as Add-on Therapy in Hypertriglyceridemic Subjects Treated With Antara (Fenofibrate) Followed by an 8-week Extension
Status: Completed Condition: Hypertriglyceridemia

Evaluation of Efficacy and Safety of Combined Omacor (Omega-3-acid Ethyl Esters) and Simvastatin Therapy in Hypertriglyceridemic Subjects
Status: Completed Condition: Hypertriglyceridemia

A Second Open-Label Extension of a Double-Blind, Parallel, Phase IV Study to Assess the Efficacy and Safety of Adjunctive Lovaza® (Formerly Known as Omacor®) Therapy in Hypertriglyceridemic Subjects Treated With Antara™
Status: Completed Condition: Hypertriglyceridemia

Evaluation of Efficacy and Safety of Omacor, Co-Administered With Atorvastatin, in Subjects With Hypertriglyceridemia
Status: Completed Condition: Hypertriglyceridemia

Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lovaza® and Simvastatin Therapy in Hypertriglyceridemic Subjects
Status: Completed Condition: Hypertriglyceridemia

Evaluation of Efficacy and Safety of Lovaza (Omega-3-Acid Ethyl Esters) in Recurrent, Symptomatic Atrial Fibrillation
Status: Completed Condition: Fibrillation, Atrial; Atrial Fibrillation

Effects of Lovaza on High Density Lipoprotein (HDL) Composition and Function in Hypertriglyceridemia
Status: Withdrawn Condition: Hypertriglyceridemia

Omacor and Cardiovascular Risk Factors in HIV Patients on HAART Treatment
Status: Completed Condition: Human Immunodeficiency Virus; Ischemic Heart Disease

An Efficacy and Safety Study of Omacor® in Taiwanese Hypertriglyceridemic Patients
Status: Active, not recruiting Condition: Hypertriglyceridemia

Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease
Status: Recruiting Condition: Non-Alcoholic Fatty Liver Disease

Courtesy of ClinicalTrials.org
See more clinical trials for this drug

Litigation for: ESTERS

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    • Glossary
    Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Product Substance Delist_Flag Patent Expiration Patented / Exclusive Use
    Smithkline Beecham
    LOVAZA
    omega-3-acid ethyl esters
    		CAPSULE; ORAL021654Nov 10, 2004RXYes7,732,488YY<disabled>
    Smithkline Beecham
    LOVAZA
    omega-3-acid ethyl esters
    		CAPSULE; ORAL021654Nov 10, 2004RXYes5,502,077Y<disabled>USE IN LIPID MANAGEMENT
    Smithkline Beecham
    LOVAZA
    omega-3-acid ethyl esters
    		CAPSULE; ORAL021654Nov 10, 2004RXYes5,656,667YY<disabled>USE IN LIPID MANAGEMENT
    Smithkline Beecham
    LOVAZA
    omega-3-acid ethyl esters
    		CAPSULE; ORAL021654Nov 10, 2004RXYes<disabled>INCLUSION OF RESULTS FROM TWO DRUG INTERACTION STUDIES WITH LIPITOR AND CRESTOR IN CLINICAL PHARMACOLOGY SECTION
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