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Exemed Pharmaceutical Gets CDSCO Panel Nod To Manufacture, Market Empagliflozin plus Sitagliptin FDC

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-08-28T18:15:56+05:30  |  Updated On 28 Aug 2024 6:15 PM IST
Exemed Pharmaceutical Gets CDSCO Panel Nod To Manufacture, Market Empagliflozin plus Sitagliptin FDC
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New Delhi: Exemed Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market the fixed-dose combination (FDC) antidiabetic drug for two strengths, i.e. Empagliflozin 10 mg/25 mg plus Sitagliptin 100 mg/100 mg film-coated tablet.

This came after Exemed Pharmaceutical presented the proposal along with a Phase III clinical trial report for two strengths, i.e. Empagliflozin 10 mg/25 mg plus sitagliptin 100 mg/100 mg film-coated tablet, before the committee.

Empagliflozin is an inhibitor of sodium-glucose co-transporter-2 (SGLT2), the transporters primarily responsible for the reabsorption of glucose in the kidney. It is used clinically as an adjunct to diet and exercise, often in combination with other drug therapies, for the management of type 2 diabetes mellitus.

Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used in conjunction with diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. The effect of this medication leads to glucose-dependent increases in insulin and decreases in glucagon to improve control of blood sugar. Sitagliptin was granted FDA approval on October 16, 2006.

Inhibition of DPP-4 by sitagliptin slows DPP-4-mediated inactivation of incretins like GLP-1 and GIP. Incretins are released throughout the day and upregulated in response to meals as part of glucose homeostasis. Reduced inhibition of incretins increases insulin synthesis and decreases glucagon release in a manner dependent on glucose concentrations. These effects lead to an overall increase in blood glucose control, which is demonstrated by reduced glycosylated hemoglobin (HbA1c).

At the recent SEC meeting for endocrinology and metabolism held on 22nd August 2024, the expert panel reviewed the proposal along with the Phase III clinical trial report for two strengths, i.e. empagliflozin 10mg/25mg plus sitagliptin 100 mg/100 mg film-coated tablet, before the committee.

After detailed deliberation, the committee recommended a grant of permission to the manufacturer and market of the proposed FDC.

Also Read: Dr Reddy's Laboratories gets CDSCO Panel nod to study Live Attenuated Varicella Vaccine

Exemed Pharmaceuticalcdscoantidiabetic drugempagliflozinSitagliptin
Dr. Divya Colin
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

    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

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