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FDA Rebuffs Insulin Drug
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Delayed FDA approval of diabetes drug Tresiba in the U.S. market. The FDA requested additional testing data which Novo Nordisk says it cannot provide in 2013. Novo Nordisk has 27% market share in the diabetes market with its fast acting NovoLog insulin. Sanofi has 19% market share with its long acting Lantus insulin. Tresiba was approved for use in Europe. About 44% of Novo Nordisk drug sales in 2012 were in the U.S. market.
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