The Danish drugmaker said Victoza, also known as liraglutide, is meant to help lower blood sugar levels along with diet and exercise in adults with type 2 diabetes.
'The U.S. approval of Victoza represents a major advancement in the treatment of type 2 diabetes and is an important milestone for Novo Nordisk,' Lars Rebien Sorensen, Novo's chief executive, said in a statement.
Novo Nordisk has said Victoza has the potential to be a blockbuster drug, meaning annual sales of more than $1 billion.
Some analysts had expected news from the FDA before year-end, but the company said in late December that formal feedback from the U.S. had been delayed.
Novo Nordisk is vying to get Victoza into the main markets before Byetta, the rival treatment from Eli Lilly and Co and Amylin Pharmaceuticals Inc. It was approved in Europe in July and in Japan earlier this month.
(Reporting by Martinne Geller; Editing by Anshuman Daga)
((Reuters Messaging: martinne.geller.reuters.com@reuters.net; (646) 223-6023)) Keywords: NOVONORDISK (http://blogs.reuters.com/shop-talk/ for Shop Talk -- Reuters' retail and consumer blog) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
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