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Ozempic 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

Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog administered once-weekly for the treatment of adults with type 2 diabetes.

Development History and FDA Approval Process for Ozempic

DateArticle
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
Apr 28, 2016Semaglutide significantly reduces the risk of major adverse cardiovascular events in the SUSTAIN 6 trial
Feb 23, 2016Novo Nordisk successfully completes fifth phase 3a trial with semaglutide in people with type 2 diabetes
Dec 17, 2015Novo Nordisk successfully completes fourth phase 3a trial with semaglutide in people with type 2 diabetes
Aug 26, 2015Novo Nordisk to Initiate Phase 3a Development of Oral Semaglutide, a Once-Daily Oral GLP-1 Analogue
Jul 10, 2015Novo Nordisk Successfully Completes First Phase 3a Trial with Semaglutide in People with Type 2 Diabetes

Further information

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