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

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

Tradenames:3
Patents:1
Applicants:5
NDAs:5
Drug Master File Entries: see list11
Suppliers: see list6
Therapeutic Class:Cardiovascular Agents

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Status: Withdrawn Condition: Hypertriglyceridemia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
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Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Trygg
OMTRYG
omega-3-acid ethyl esters
CAPSULE;ORAL204977Apr 23, 2014RXYes<disabled><disabled>
Apotex Inc
OMEGA-3-ACID ETHYL ESTERS
omega-3-acid ethyl esters
CAPSULE;ORAL090973Sep 30, 2014RXNo<disabled><disabled>
Smithkline Beecham
LOVAZA
omega-3-acid ethyl esters
CAPSULE;ORAL021654Nov 10, 2004RXYes5,656,667<disabled>YY<disabled>
Par Pharm Inc
OMEGA-3-ACID ETHYL ESTERS
omega-3-acid ethyl esters
CAPSULE;ORAL091018Jun 24, 2014RXNo<disabled><disabled>
Teva Pharms Usa
OMEGA-3-ACID ETHYL ESTERS
omega-3-acid ethyl esters
CAPSULE;ORAL091028Apr 7, 2014RXNo<disabled><disabled>
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