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Medical Devices / Submissions and Approvals

Novo Nordisk Wins FDA Nod for Fast-Acting Mealtime Insulin

Oct. 4, 2017
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Novo Nordisk wins FDA approval its Fiasp insulin aspart injection for fast-acting mealtime insulin. The device is designed to improve glycemic control for adults with Type I and Type II diabetes.

The device is a redesigned formulation of the NovoLog product, with added vitamin B3 to boost initial insulin absorption and trigger an onset of appearance in the blood in 2.5 minutes.

The approval was supported by a Phase IIIa clinical trial involving more than 2,000 individuals with Type I and Type II diabetes.

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