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Rybelsus FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 12, 2024.

FDA Approved: Yes (First approved September 20, 2019)
Brand name: Rybelsus
Generic name: semaglutide
Dosage form: Tablets
Company: Novo Nordisk
Treatment for: Type 2 Diabetes

Rybelsus (semaglutide) is an oral glucagon-like peptide-1 (GLP-1) receptor agonist indicated for the treatment of adults with type 2 diabetes mellitus.

Development timeline for Rybelsus

DateArticle
Mar  5, 2024Semaglutide Reduces Severity of Common Liver Disease in People with HIV
Jan 12, 2023Approval Novo Nordisk Announces FDA Approval of Label Update for Rybelsus (semaglutide) Allowing Use as a First-Line Option for Adults with Type 2 Diabetes
Sep 20, 2019Approval FDA Approves Rybelsus (semaglutide), the First Oral GLP-1 Analog Treatment for Adults with Type 2 Diabetes
Mar 26, 2019Novo Nordisk Files for US FDA Approval of Oral Semaglutide for Blood Sugar Control and Cardiovascular Risk Reduction in Adults with Type 2 Diabetes

See also

Rybelsus (semaglutide) Consumer information

Further information

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