CDSCO panel approves AstraZeneca’s proposal for Amendment in Package Insert for Saxagliptin tablets

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major AstraZeneca’s proposal for amendment in Package Insert from Version-11 to Version-12 for drug Onglyza (Saxagliptin) tablets 2.5mg and 5mg.

This came after the firm presented the proposal for amendment in Package Insert from Version-11 to Version-12 for the drug Onglyza (Saxagliptin) tablets 2.5mg and 5mg.

Onglyza (Saxagliptin) is a prescription medication used in combination with diet and exercise to help manage blood sugar levels in adults with type 2 diabetes. Saxagliptin is a DPP-4 inhibitor used for the management of type 2 diabetes mellitus.

Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor antidiabetic for the treatment of type 2 diabetes. DPP-4 inhibitors are a class of compounds that work by affecting the action of natural hormones in the body called incretins. Incretins decrease blood sugar by increasing consumption of sugar by the body, mainly through increasing insulin production in the pancreas, and by reducing production of sugar by the liver.

At the recent SEC meeting for Endocrinology and Metabolism held on July 11, 2024, the expert panel reviewed the proposal for amendment in Package Insert from Version-11 to Version-12 for the drug Onglyza (Saxagliptin) tablets 2.5mg and 5mg.

After detailed deliberation, the committee recommended the approval of the amendment in PI from Version-11 to Version-12 for the drug Onglyza (Saxagliptin) tablets 2.5mg and 5mg.

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