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Ozempic FDA Approval History

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

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

Development timeline for Ozempic

DateArticle
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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