Posted by Michael Wonder on 20 Dec 2016
Novo Nordisk receives FDA approval of Tresiba (insulin degludec injection 100 U/mL, 200 U/mL) for use in children and adolescents with diabetes
19 December 2016 - Novo Nordisk today announced that the U.S. FDA approved an expanded indication for Tresiba (insulin degludec injection 100 U/mL, 200 U/mL), a once-daily, long-acting basal insulin, to be used in children and adolescents with diabetes.
Tresiba, first approved by the FDA in September 2015, is now indicated to improve glycemic control in patients with type 1 and type 2 diabetes from the age of one through adulthood, making it the only basal insulin approved for both type 1 and type 2 diabetes in patients as young as 1 year old.
Tresiba is a long-acting insulin that is released over time, has a 25 hour half-life and has a consistently flat and stable profile at steady state.
