Abbott’s Omacor For Triglyceride Level Reduction Clears FDA
This article was originally published in The Pink Sheet Daily
Executive Summary
The omega-3-acid ethyl esters product is indicated as an adjunct to diet in the reduction of “very high” triglyceride levels. Solvay markets Omacor in Europe; Reliant is expected to market Omacor in the U.S.
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Abbott's Omacor (omega-3-acid ethyl esters) cleared FDA for the treatment of hypertriglyceridemia in adults Nov. 10. Abbott's Ross Products division submitted the NDA (21-654) for Omacor on Jan. 20 and received a standard review. "Omacor is indicated as an adjunct to diet to reduce very high (> 500 mg/dL) triglyceride (TG) levels in adult patients," labeling states. Solvay licenses Omacor from Pronova Biocare in the U.K., Germany, Ireland, Greece, Austria, Belgium, Switzerland, the Netherlands and Luxembourg. Omacor is registered in overseas markets as an adjuvant treatment in secondary prevention after myocardial infarction and for primary treatment of hypertriglyceridemia. Reliant is expected to market Omacor in the U.S. using product manufactured by Cardinal. Reliant also markets Novartis' statin Lescol XL (fluvastatin). On Sept. 8, FDA approved a "qualified health claim" for reduced risk of coronary heart disease for conventional foods containing omega-3 fatty acids. - Adam Eckstein |