Semaglutide prescription to be restricted to endocrinologists only: CDSCO panel tells Novo Nordisk
New Delhi: In a major development, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has granted marketing authorization to Novo Nordisk India for the anti-diabetic drug, Semaglutide 0.25 mg, 0.5 mg, 1 mg, 1.7 mg & 2.4 mg (Pre-filled pen) in line with the USFDA approved indication.
However, the expert panel has clarified that the prescription of the said drug should be restricted to endocrinologists only.
The approval came in the wake of a proposal moved by Novo Nordisk India Pvt. Ltd. for marketing authorization of the anti-diabetic drug, Semaglutide 0.25 mg, 0.5 mg, 1 mg, 1.7 mg & 2.4 mg (Pre-filled pen) with data generated on Indian patients before the committee.
Semaglutide is a glucagon-like peptide 1 receptor agonist which is used to improve glycemic control in type 2 diabetes mellitus. Semaglutide acts by binding to and activating the GLP-1 receptor, thereby stimulating insulin secretion and reducing blood glucose.
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