Synokem gets CDSCO Panel Nod To Study FDC Dapagliflozin plus Sacubitril plus Valsartan
New Delhi: The drug major Synokem Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the bioequivalence (BE) study of the fixed-dose combination (FDC) Dapagliflozin Propanediol Monohydrate plus Sacubitril plus Valsartan Sodium Salt Film Coated Tablets.
This came after Synokem Pharmaceutical presented its proposal and the BE study protocol before the committee.
Dapagliflozin works by increasing the removal of sugar by your kidneys. Dapagliflozin is also used to treat kidney disease and heart failure. It helps to lower the risk of death from heart disease and reduces the need to go to a doctor or hospital to treat heart failure.
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.
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