 Prasugrel (Effient): FDA Needs More Time to Review, Say Lilly and Daiichi (Update)Daiichi Sankyo Co. and Eli Lilly confirmed today that the U.S. Food and Drug Administration did not complete its review for the prasugrel new drug application. The proposed indication for prasugrel is for the treatment of patients with acute coronary syndromes being managed with an artery-opening procedure known as percutaneous coronary intervention.
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Eli Lilly and Co and Daiichi Sankyo Co Ltd said that Food and Drug Administration have not completed a review of their anti-clotting drug prasugrel. ``This is a very large, complex submission, and it should not be surprising that delays occur,'' Lilly's vice president for global regulatory affairs, Jennifer Stotka, said today in a PR Newswire statement issued by Lilly and partner Daiichi Sankyo Co. The product is vital to plans by Indianapolis-based Lilly to replace lost revenue when its top-seller, the antipsychotic Zyprexa, loses patent protection in 2011. The proposed indication for prasugrel is for the treatment of patients with acute coronary syndromes (ACS) being managed with an artery-opening procedure known as percutaneous coronary intervention Prasugrel (Effient) is expected to compete directly with Plavix, the blood clot preventer sold by Bristol-Myers Squibb Co and Sanofi-Aventis SA.
 I see more clical trail info before approval. This is BAD.
Published by: Bryan Casella | 09-26-2008 | 21:50
The axe is coming at lilly.
Published by: victoria smith | 09-26-2008 | 21:08
Thanks for that jpg
Published by: james | 09-26-2008 | 20:45
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