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

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-08-12T17:30:07+05:30 | Updated On 12 Aug 2024 5:30 PM IST

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.

Also Read: Eli Lilly Gets CDSCO Panel Nod to Study Retatrutide

saxagliptinOnglyza Tabletscdscotype 2 diabetesdpp4 inhibitor

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751