liraglutide

FDA Drug Profile — liraglutide, Liraglutide, Saxenda, Victoza

Drug Details

Generic Name
liraglutide
Brand Names
liraglutide, Liraglutide, Saxenda, Victoza
Application Number
ANDA217234
Sponsor
Cipla USA Inc.
NDC Codes
14
Dosage Forms
INJECTION, SOLUTION, INJECTION, POWDER
Routes
SUBCUTANEOUS
Active Ingredients
LIRAGLUTIDE

Indications and Usage

1 INDICATIONS AND USAGE Liraglutide injection is indicated in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: Adults and pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity. Adults with overweight in the presence of at least one weight-related comorbid condition. Limitations of Use Liraglutide injection contains liraglutide. Coadministration with other liraglutide-containing products or with any other glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended. The safety and effectiveness of liraglutide injection in pediatric patients with type 2 diabetes have not been established. Liraglutide injection is a glucagon like peptide 1 (GLP-1) receptor agonist indicated in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: • Adults and Pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity. ( 1 ) • Adults with overweight in the presence of at least one weight-related comorbid condition. ( 1 ) Limitations of Use: Coadministration with other liraglutide-containing products or with any other GLP-1 receptor agonist is not recommended. ( 1 ) The safety and effectiveness of liraglutide injection in pediatric patients with type 2 diabetes have not been established. ( 1 )