semaglutide
Drug Details
- Generic Name
- semaglutide
- Brand Names
- Ozempic, WEGOVY, OZEMPIC
- Application Number
- NDA209637
- Sponsor
- Catalent Indiana, LLC
- NDC Codes
- 46
- Dosage Forms
- INJECTION, SOLUTION, POWDER, TABLET
- Routes
- SUBCUTANEOUS, ORAL
- Active Ingredients
- SEMAGLUTIDE
Indications and Usage
1 INDICATIONS AND USAGE OZEMPIC is indicated: • as an adjunct to diet and exercise to improve glycemic control in adults 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. Limitations of Use • OZEMPIC has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis [see Warnings and Precautions ( 5.2 )] . • OZEMPIC is not indicated for use in patients with type 1 diabetes mellitus. OZEMPIC is a glucagon-like peptide 1 (GLP-1) receptor agonist indicated as: • an adjunct to diet and exercise to improve glycemic control in adults 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: • Has not been studied in patients with a history of pancreatitis. Consider another antidiabetic therapy ( 1 , 5.2 ). • Not for treatment of type 1 diabetes mellitus ( 1 ).