liraglutide

FDA Drug Profile — liraglutide, Liraglutide, Victoza, Saxenda

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.