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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 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 in adults with type 2 diabetes mellitus and established cardiovascular disease.

Development Timeline for Ozempic

DateArticle
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

Further information

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