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

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.