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insulin glargine

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

Drug Details

Generic Name
insulin glargine
Brand Names
Insulin glargine U-300, Lantus Solostar, TOUJEO, Lantus, TOUJEO Max, Insulin Glargine Solostar, LANTUS SOLOSTAR, Insulin glargine U-300 Max
Application Number
BLA206538
Sponsor
Sanofi-Aventis U.S. LLC
NDC Codes
12
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.