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Rybelsus FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 6, 2020.

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

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

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

Further information

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