insulin glargine-aldy

FDA Drug Profile — LANGLARA

insulin glargine-aldy is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including LANGLARA. Available dosage form: injection, solution.

Drug Details

Generic Name
insulin glargine-aldy
Brand Names
LANGLARA
Application Number
BLA761412
Sponsor
Lanexa Biologics, LLC
NDC Codes
1
Dosage Forms
INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients
INSULIN GLARGINE

Indications and Usage

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