insulin glargine-yfgn

FDA Drug Profile — INSULIN GLARGINE, SEMGLEE

Drug Details

Generic Name
insulin glargine-yfgn
Brand Names
INSULIN GLARGINE, SEMGLEE
Application Number
BLA761201
Sponsor
Civica, Inc.
NDC Codes
4
Dosage Forms
INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients
INSULIN GLARGINE

Indications and Usage

1 INDICATIONS AND USAGE SEMGLEE is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use SEMGLEE is not recommended for the treatment of diabetic ketoacidosis. SEMGLEE 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 )