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Novo Nordisk says FDA approval for Tresiba could come end-2015
August 7, 2014 / 6:46 AM / 3 years ago

Novo Nordisk says FDA approval for Tresiba could come end-2015

COPENHAGEN, Aug 7 (Reuters) - Novo Nordisk could receive an approval from the U.S. Food and Drug Administration for Tresiba by the end of next year, paving the way for its launch in the United States at the start of 2016, the company’s chief executive said on Thursday.

“Sometime in the first half (of 2015) we will be able to submit this additional data to the FDA, then the FDA has six months to review this. If we calculate the best possible scenario then we could see an approval by the end of the year meaning a launch into the beginning of 2016,” Lars Rebien Sorensen told journalists on a call. (Reporting by Ole Mikkelsen, Stine Jacobsen, editing by Mia Shanley)

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