Zydus Group has been granted final approval from the US health regulator to market diabetes medication Dapagliflozin tablets. The company said it has received permission to sell its drug in the American market. The drugmaker has received final approval from the US Food and Drug Administration (USFDA) to market the drug in the strengths of 5 mg and 10 mg.
Dapagliflozin is used with a proper diet and exercise programme to control high blood sugar in people with type 2 diabetes. The drug also lowers the risk of heart failure in adults with type 2 diabetes with heart disease.
It is also used to lower the risk of further worsening of kidney disease, end-stage kidney disease (ESKD), death due to cardiovascular disease, and hospitalisation for heart failure in adults with chronic kidney disease.
Dapagliflozin works by increasing the removal of sugar by kidneys. The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad, Zydus Group stated. The group now has 328 approvals and has so far filed over 400 abbreviated new drug applications (ANDAs) since the commencement of the filing process in 2003-04.
