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Novo Nordisk to update prescription label of diabetes drug

Novo Nordisk A/S said it received the U.S. Food and Drug Administration's approval to update the prescription label of its diabetes medicine Tresiba.

The updated label will reflect results from the Devote study, which showed that Tresiba was less likely to cause hypoglycemia in type 2 diabetes patients when compared to Sanofi's Lantus.

Hypoglycemia, commonly caused by medications to treat diabetes, is characterized by abnormally low blood glucose, which results in a variety of symptoms such as clumsiness, trouble talking and, in extreme cases, unconsciousness and death.

The label will also now indicate that Tresiba is just as safe as Lantus in patients at risk of having major adverse cardiovascular events, such as a heart attack or a stroke.