insulin glargine

FDA Drug Profile — Insulin Glargine, Insulin glargine U-300, Lantus Solostar, Lantus, TOUJEO

Drug Details

Generic Name
insulin glargine
Brand Names
Insulin Glargine, Insulin glargine U-300, Lantus Solostar, Lantus, TOUJEO, Insulin Glargine Solostar, Insulin glargine U-300 Max, LANTUS SOLOSTAR, TOUJEO Max
Application Number
BLA021081
Sponsor
Winthrop U.S.
NDC Codes
15
Dosage Forms
INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients
INSULIN GLARGINE

Indications and Usage

1 INDICATIONS AND USAGE LANTUS is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. LANTUS is a long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ( 1 ) Limitations of Use Not recommended for the treatment of diabetic ketoacidosis. ( 1 ) Limitations of Use LANTUS is not recommended for the treatment of diabetic ketoacidosis.