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Generic Name: omega-3-acid ethyl esters

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

Tradenames:3
Patents:1
Applicants:4
NDAs:4
Drug Master File Entries: see list10
Suppliers: see list6
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: omega-3-acid ethyl esters

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

Evaluation of Efficacy and Safety of Omacor, Co-Administered With Atorvastatin, in Subjects With Hypertriglyceridemia
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

Phase 3 Study to Evaluate the Efficacy and Safety of Omega-3-acids Ethylesters 90 in Type Ⅱb Hyperlipidemia
Status: Recruiting Condition: Hyperlipidemia, Familial Combined

The Effect of Phytosterol Esters of Omega-3 (Vayarol) Versus Omega-3 Acids Ethyl Esters in Reducing Triglyceride Levels
Status: Active, not recruiting Condition: Patients With 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

An Efficacy and Safety Study of Omacor® in Taiwanese Hypertriglyceridemic Patients
Status: Completed Condition: Hypertriglyceridemia

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Status: Withdrawn Condition: Hypertriglyceridemia

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

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Smithkline Beecham
LOVAZA
omega-3-acid ethyl esters
CAPSULE;ORAL021654Nov 10, 2004RXYes5,656,667<disabled>YYUSE IN LIPID MANAGEMENT
Par Pharm Inc
OMEGA-3-ACID ETHYL ESTERS
omega-3-acid ethyl esters
CAPSULE;ORAL091018Jun 24, 2014RXNo<disabled>
Teva Pharms Usa
OMEGA-3-ACID ETHYL ESTERS
omega-3-acid ethyl esters
CAPSULE;ORAL091028Apr 7, 2014RXNo<disabled>
Trygg
OMTRYG
omega-3-acid ethyl esters
CAPSULE;ORAL204977Apr 23, 2014RXYes<disabled>
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