Zydus receives final approval from USFDA for Dapagliflozin Tablets

NEW DELHI: Zydus said that it has received final approval from the USFDA to market Dapagliflozin Tablets in the strengths of 5 mg and 10 mg (USRLD: Farxiga).

Dapagliflozin is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Dapagliflozin 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 hospitalization 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.

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.