Novo Nordisk seeks to include cardiovascular data in Tresiba insulin label

Novo Nordisk (NYSE:NVO) said today that it submitted a supplemental application to the FDA, asking to include cardiovascular data on the label of its Tresiba insulin degludec.
The Danish insulin-maker asked to include data specifically from the Devote trial, which evaluated the cardiovascular safety of Tresiba compared to insulin glargine in patients with Type II diabetes.
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Source: Mass Device - May 30, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials Diabetes Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Wall Street Beat Novo Nordisk Source Type: news