Sun Pharma Gets CDSCO Panel Nod To Market Sitagliptin, Metformin, Glimepiride FDC in Lower Strength
New Delhi: Pharmaceutical major Sun Pharma has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to manufacture and market the fixed-dose combination antidiabetic drug Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg/50mg plus Metformin Hydrochloride IP 500mg/500mg plus Glimepiride IP 1mg/2mg film-coated tablet.
This came after the drug major Sun Pharma presented their proposal for a bioequivalence (BE) study and Phase III clinical trial wavier for lower strength i.e. Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg/50mg plus Metformin Hydrochloride IP 500mg/500mg plus Glimepiride IP 1mg/2mg film-coated tablet based on Phase III clinical trial and BE study results presented for higher strength i.e. Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg/50mg plus Metformin Hydrochloride IP 1000mg/1000mg plus Glimepiride IP 1mg/2mg film-coated tablet.
Sitagliptin phosphate monohydrate is an oral antihyperglycemic (antidiabetic drug) of the dipeptidyl peptidase-4 (DPP-4) inhibitor class. Sitagliptin phosphate works to competitively inhibit the enzyme dipeptidyl peptidase 4 (DPP-4). Sitagliptin is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. It is used in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems.
Metformin is an oral anti-diabetic drug in the biguanide class for the treatment of type 2 diabetes mellitus, in particular, in overweight and obese people and those with normal kidney function. Metformin is used to treat high blood sugar levels that are caused by a type of diabetes mellitus or sugar diabetes called type 2 diabetes. With this type of diabetes, insulin produced by the pancreas is not able to get sugar into the cells of the body where it can work properly.
Glimepiride is a medication used in the management and treatment of type 2 diabetes mellitus. It is in the sulfonylurea class of drugs. Glimepiride is used to treat high blood sugar levels caused by type 2 diabetes. It may be used alone or in combination with insulin or another oral medicine such as metformin. In type 2 diabetes, insulin produced by the pancreas is not able to get sugar into the cells of the body where it can work properly.
At the recent SEC meeting for Endocrinology and Metabolism held on 19th September 2023, the expert panel reviewed the proposal presented by the drug major Sun Pharma for BE study and Phase III clinical trial waiver for the lower strength of the FDC Antidiabetic Drug Sitagliptin Phosphate Monohydrate plus Metformin Hydrochloride plus Glimepiride film-coated tablet along with the BE study report for the higher strength i.e. Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg/50mg plus Metformin Hydrochloride IP 1000mg/1000mg plus Glimepiride IP 1mg/2mg film-coated tablet.
After detailed deliberation, the committee recommended the grant of permission to manufacture and market the product in the lower strength.
