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Ozempic FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 28, 2025.

FDA Approved: Yes (First approved December 5, 2017)
Brand name: Ozempic
Generic name: semaglutide
Dosage form: Injection
Company: Novo Nordisk
Treatment for: Type 2 Diabetes, Cardiovascular Risk Reduction, Chronic Kidney Disease

Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog for the treatment type 2 diabetes, to reduce the risk of major cardiovascular events in patients with type 2 diabetes and cardiovascular disease, and to reduce the risk of worsening kidney disease and cardiovascular death in patients with type 2 diabetes and chronic kidney disease.

Development timeline for Ozempic

DateArticle
Jan 28, 2025Approval FDA Approves Ozempic (semaglutide) as the Only GLP-1 RA to Reduce the Risk of Worsening Kidney Disease and Cardiovascular Death in Adults with Type 2 Diabetes and Chronic Kidney Disease
Mar  5, 2024Semaglutide Reduces Severity of Common Liver Disease in People with HIV
Mar 28, 2022Approval Novo Nordisk Receives FDA Approval of Higher-Dose Ozempic 2 mg Providing Increased Glycemic Control for Adults with Type 2 Diabetes
Jan 16, 2020Approval FDA Approves Ozempic (semaglutide) for Cardiovascular Risk Reduction in Adults with Type 2 Diabetes and Known Heart Disease
Dec  5, 2017Approval Novo Nordisk Receives FDA Approval of Ozempic (semaglutide) Injection For the Treatment of Adults with Type 2 Diabetes
Oct 18, 2017Novo Nordisk Receives Positive 16-0 vote from FDA Advisory Committee in Favor of Approval for Semaglutide
Dec  5, 2016Novo Nordisk Files for Regulatory Approval of Once-Weekly Semaglutide with the FDA for the Treatment of Type 2 Diabetes

See also

Ozempic (semaglutide) Consumer information

Further information

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