12 March, 2009 -- Pronova BioPharma ASA today announces that it and its U.S. marketing partner GlaxoSmithKline Inc. have received a Paragraph IV Notice Letter dated March 9 2009 from Teva Pharmaceuticals USA, Inc. advising that Teva has submitted an Abbreviated New Drug Application (ANDA) to the US FDA for approval to market a generic version of Lovaza.
the details can be read here.
1 comment:
Can anybody explain why it is possible to file a patent application in the U.S. with facts that have been already public in other regions of the world for years. E.g. regarding LOVAZA this product was introduced first around 1984 in Europe for triglyceride lowering under the name K85 later called Omacor manufactured by Norsk Hydro and promoted by Pharmacia. Pronova is a spin off of Norsk Hydro that reinvented the story. The triglyceride lowering effects were published already in the 80s of last century and the link between triglycerides and cardiovascular risk was know due to work done already with fibrates. Publication e.g. in J Oslo City Hosp. 1989 Aug-Sep;39(8-9):97-101.
Effects of highly concentrated omega-3 polyunsaturated fatty acids and acetylsalicylic acid, alone and combined, on bleeding time and serum lipid profile.Eritsland J, Arnesen H, Smith P, Seljeflot I, Dahl K.
Twenty-two patients with stable coronary heart disease were randomly assigned to either of two groups. Group I (n = 11) was given acetylsalicylic acid (ASA) 300 mg daily for 1 week, whereafter a daily supplement of 3,4 g eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) as a highly concentrated ethylester, formulation ("K-85", Norsk Hydro) was added for another 4 weeks. Group II (n = 11) was given 3,4 g daily of EPA and DHA for 4 weeks, after which ASA 300 mg daily was added for another week. Determination of serum fatty acids confirmed satisfying absorption of EPA and DHA. A significant increase of the Ivy bleeding time was registered following administration of both "K-85" (240 to 270 sec, median values) and ASA (270 to 360 sec, median values) alone. A slighter increase was noted by a combination of the two principles. A reduction in serum triglycerides of 17% was noted after "K-85" (median values, both groups). Serum total cholesterol decreased after "K-85" administration in group I, but not so in group II. HDL-cholesterol remained unchanged. Serum lipids remained unaffected by ASA. During administration of "K-85" no adverse effects or bleeding episodes were seen.
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