semaglutide

FDA Drug Profile — WEGOVY, Ozempic, OZEMPIC

semaglutide is listed in the FDA National Drug Code directory with 50 NDC codes, marketed under brand names including WEGOVY, Ozempic, OZEMPIC. Available dosage forms: powder, injection, solution, tablet.

Drug Details

Generic Name
semaglutide
Brand Names
WEGOVY, Ozempic, OZEMPIC
Application Number
NDA215256
Sponsor
Nanjing Hanxin Pharmaceutical Technology Co., Ltd.
NDC Codes
50
Dosage Forms
POWDER, INJECTION, SOLUTION, TABLET
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).