liraglutide
Drug Details
- Generic Name
- liraglutide
- Brand Names
- liraglutide, Liraglutide, Victoza, Saxenda
- Application Number
- ANDA217234
- Sponsor
- Cipla USA Inc.
- NDC Codes
- 15
- Dosage Forms
- INJECTION, SOLUTION, INJECTION, POWDER
- Routes
- SUBCUTANEOUS
- Active Ingredients
- LIRAGLUTIDE
Indications and Usage
1 INDICATIONS AND USAGE VICTOZA is indicated: • as an adjunct to diet and exercise to improve glycemic control in patients 10 years and older with type 2 diabetes mellitus, • to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease [see Clinical Studies ( 14.3 )] . Limitations of Use : VICTOZA should not be used in patients with type 1 diabetes mellitus. VICTOZA contains liraglutide and should not be coadministered with other liraglutide-containing products. VICTOZA is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated: • as an adjunct to diet and exercise to improve glycemic control in patients 10 years and older with type 2 diabetes mellitus (1) . • to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease ( 1 ). Limitations of Use : • Not for treatment of type 1 diabetes mellitus. • Should not be coadministered with other liraglutide-containing products.