insulin degludec

FDA Drug Profile — TRESIBA, Tresiba, Insulin Degludec

Drug Details

Generic Name
insulin degludec
Brand Names
TRESIBA, Tresiba, Insulin Degludec
Application Number
BLA203314
Sponsor
A-S Medication Solutions
NDC Codes
11
Dosage Forms
INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients
INSULIN DEGLUDEC

Indications and Usage

1 INDICATIONS AND USAGE TRESIBA is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. Limitations of Use • Not recommended for the treatment of diabetic ketoacidosis. TRESIBA is a long-acting human insulin analog indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus ( 1 ). Limitations of Use: • Not recommended for the treatment of diabetic ketoacidosis.