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news.Laboratorios Ferrer, a Spanish partner of Pronova BioPharma, has received marketing authorisation from the Mexican health authorities for the treatment of elevated levels of triglycerides in humans, hypertriglyceridemia (HTG) and the secondary prevention of post-myocardial infarction (post-MI).
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Pronova BioPharma’s first commercialized product is branded as Omacor in a number of countries throughout Europe and Asia and as Lovaza in the US.
Pronova BioPharma CEO Morten Jurs said that they expect Omacor/Lovaza to be approved in Mexico in the coming years.
Omacor/Lovaza, an omega-3 derived prescription drug has received both EU and the US Food and Drug Administration approval, indicated as an adjunct to diet for the treatment of HTG.
Omacor is also approved in key European and certain Asian markets for the secondary prevention of post-myocardial infarction.
Omacor/Lovaza has demonstrated in a number of clinical trials to be a potent triglyceride-lowering agent as a monotherapy.
Pronova BioPharma is engaged in the research, development and manufacture of marine-originated omega-3 derived pharmaceutical products.