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Tradename: LOVAZA
Summary for Tradename: LOVAZA
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| Pharmacology for Tradename: LOVAZA
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Clinical Trials for: LOVAZAEvaluation 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 Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease Status: Recruiting Condition: Non-Alcoholic Fatty Liver Disease 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 Effects of Lovaza on High Density Lipoprotein (HDL) Composition and Function in Hypertriglyceridemia Status: Withdrawn Condition: Hypertriglyceridemia Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lovaza® and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 Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia Status: Completed Condition: Hypertriglyceridemia Trial of Lovaza in Adolescents With Mild to Moderately Elevated Triglycerides Status: Terminated Condition: Hypertriglyceridemia Pilot Study of Lovaza (Omega 3 Fatty Acids) to Improve Heart Function in Patients With Mitral Valve Disease Status: Recruiting Condition: Mitral Valve Regurgitation; Left Atrium Dilatation and Hypertrophy; Mitochondrial Dysfunction in the Heart; Cardiomyocyte Apoptosis; Cardiac Inflammation Courtesy of ClinicalTrials.org See more clinical trials for this drug | ||||||||||||||||
Glossary
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Product | Substance | Delist_Flag | Patent Expiration | Exclusivity Expiration | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Smithkline Beecham | LOVAZA | omega-3-acid ethyl esters | CAPSULE; ORAL | 021654 | Nov 10, 2004 | RX | Yes | <disabled> | <disabled> | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Smithkline Beecham | LOVAZA | omega-3-acid ethyl esters | CAPSULE; ORAL | 021654 | Nov 10, 2004 | RX | Yes | 5,502,077 | Y | <disabled> | <disabled> | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Smithkline Beecham | LOVAZA | omega-3-acid ethyl esters | CAPSULE; ORAL | 021654 | Nov 10, 2004 | RX | Yes | 5,656,667 | Y | Y | <disabled> | <disabled> | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Smithkline Beecham | LOVAZA | omega-3-acid ethyl esters | CAPSULE; ORAL | 021654 | Nov 10, 2004 | RX | Yes | 7,732,488 | Y | Y | <disabled> | <disabled> | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Paragraph IV activity for: LOVAZA
| Drugname | Dosage | Strength | RLD | Submissiondate |
| omega-3-acid ethyl esters | Capsules | 1 g | Lovaza | 11/10/2008 |
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