Abbott Gets CDSCO Panel Nod To Study Antidiabetic FDC Dapagliflozin plus Metformin
New Delhi: The drug major Abbott Healthcare has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the bioequivalence (BE) study of the fixed-dose combination (FDC) of the antidiabetic drug Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin plus Metformin Hydrochloride IP (sustained released)...
New Delhi: The drug major Abbott Healthcare has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the bioequivalence (BE) study of the fixed-dose combination (FDC) of the antidiabetic drug Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin plus Metformin Hydrochloride IP (sustained released) (10mg+500mg/ 10mg+1000mg) film-coated tablets.
This came after Abbott Healthcare presented its proposal along with the BE study waiver justification of the FDC of the antidiabetic drug Dapagliflozin Propanediol monohydrate plus Metformin Hydrochloride film-coated tablets.
Dapagliflozin Propanediol is the propanediol form of dapagliflozin, a selective sodium-glucose co-transporter subtype 2 (SGLT2) inhibitor with antihyperglycemic activity. Upon administration, dapagliflozin selectively targets and inhibits SGLT2, thereby preventing the reabsorption of glucose by the kidneys. Dapagliflozin is used with a proper diet and exercise program to control high blood sugar 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 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. Metformin exerts its prevailing, glucose-lowering effect by inhibiting hepatic gluconeogenesis and opposing the action of glucagon.
Dapagliflozin and metformin combination is used together with proper diet and exercise to treat type 2 diabetes. It is also used to lower the risk of hospitalization for heart failure in patients with type 2 diabetes and cardiovascular (heart or blood vessel) disease or multiple cardiovascular risk factors.
At the recent SEC meeting for Endocrinology and Metabolism held on 27th and 29th September 2023, the expert panel reviewed the proposal along with BE study waiver justification of the FDC antidiabetic drug Dapagliflozin Propanediolmonohydrate plus Metformin Hydrochloride film-coated tablets
The committee noted that the proposed FDC was already approved by CDSCO on 16.10.2017. After detailed deliberation, the committee recommended conducting the BE study with the proposed FDC.
Also Read:CDSCO Panel approves Exemed Pharmaceutical to study Montelukast, Bilastine FDC Tablet
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