What is the generic name?

ORAL SEMAGLUTIDE

What is the Trade Name for ORAL SEMAGLUTIDE?

RYBELSUS

What are the Indications for ORAL SEMAGLUTIDE?

• 1 INDICATIONS AND USAGE RYBELSUS is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies ( 14.1 )] . Limitations of Use ‚Ä¢ RYBELSUS is not recommended as a first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans [see Warnings and Precautions ( 5.1 )]. ‚Ä¢ RYBELSUS has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis [see Warnings and Precautions ( 5.2 )] . ‚Ä¢ RYBELSUS is not indicated for use in patients with type 1 diabetes mellitus. RYBELSUS is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus ( 1 ). Limitations of Use ‚Ä¢ Not recommended as first-line therapy for patients inadequately controlled on diet and exercise ( 1 , 5.1 ). ‚Ä¢ Has not been studied in patients with a history of pancreatitis ( 1 , 5.2 ). ‚Ä¢ Not for treatment of type 1 diabetes mellitus ( 1 ).

References: https://open.fda.gov/