semaglutide
Drug Details
- Generic Name
- semaglutide
- Brand Names
- Ozempic, WEGOVY, OZEMPIC
- Application Number
- NDA209637
- Sponsor
- Novo Nordisk A/S
- NDC Codes
- 50
- Dosage Forms
- INJECTION, SOLUTION, TABLET, POWDER
- Routes
- SUBCUTANEOUS, ORAL
- Active Ingredients
- SEMAGLUTIDE
Indications and Usage
1 INDICATIONS AND USAGE WEGOVY is indicated in combination with a reduced calorie diet and increased physical activity: • to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight. • to reduce excess body weight and maintain weight reduction long term in: o Adults and pediatric patients aged 12 years and older with obesity o Adults with overweight in the presence of at least one weight-related comorbid condition. Limitations of Use • WEGOVY contains semaglutide. Coadministration with other semaglutide-containing products or with any other GLP-1 receptor agonist is not recommended. WEGOVY is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated in combination with a reduced calorie diet and increased physical activity: • to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight (1) . • to reduce excess body weight and maintain weight reduction long term in: o Adults and pediatric patients aged 12 years and older with obesity o Adults with overweight in the presence of at least one weight-related comorbid condition (1) . Limitations of Use: • Coadministration with other semaglutide-containing products or with any other GLP-1 receptor agonist is not recommended (1).