Zydus receives final approval from US FDA for Dapagliflozin tablets

Zydus has received final approval from the US Food and Drug Administration (FDA) to market Dapagliflozin tablets in the strengths of 5 mg and 10 mg. Dapagliflozin is used with a proper diet and an exercise programme to control high blood sugar in people with type-II diabetes, the company said in a statement.

Dapagliflozin also lowers the risk of heart failure in adults with type-II diabetes with heart disease. It is also used to lower the risk of a 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 (CKD), added the statement.

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. The group now has 328 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04, the statement concluded.