01.01.05
Reliant Pharmaceuticals, Inc., Liberty Corner, NJ, and Pronova Biocare AS, Oslo, Norway, have reached an agreement for Reliant to market Omacor (omega 3 acid ethyl esters) in the U.S. following the product’s recent approval by FDA. Under the terms of the agreement, Reliant will have exclusive marketing and distribution rights in the U.S. and will maintain the New Drug Application (NDA). Omacor, which contains highly concentrated ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), was approved by the FDA on November 10, 2004, as an adjunct to diet for the reduction of triglycerides in adult patients with very high triglyceride levels (greater than or equal to 500 mg/dL).