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Tresiba Approval History

FDA Approved: Yes (First approved September 25, 2015)
Brand name: Tresiba
Generic name: insulin degludec
Dosage form: Injection
Company: Novo Nordisk
Treatment for: Diabetes, Type 1, Diabetes, Type 2

Tresiba (insulin degludec) is a long-acting basal insulin analogue indicated to improve glycemic control in patients one year of age and older with diabetes mellitus.

Development History and FDA Approval Process for Tresiba

Dec 19, 2016Approval Novo Nordisk Receives FDA Approval of Tresiba (insulin degludec) for Use in Children and Adolescents With Diabetes
Sep 25, 2015Approval FDA Approves Tresiba (insulin degludec) for Diabetes Mellitus
Jun 11, 2012Investigational Ultra Long-Acting Insulin Degludec Reduced Rates of Nocturnal Hypoglycemia in Type 2 Diabetes Patients Versus Insulin Glargine

Further information

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