Zydus Cadila gets tentative US FDA approval for Dapagliflozin Tablets

Zydus Cadila has received tentative approval from the USFDA to market Dapagliflozin Tablets, 5 mg and 10 mg (US RLD: Farxiga Tablets). Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and to reduce the risk of hospitalisation for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors.

Zydus Cadila is believed to be the only company with tentative approval that has submitted a paragraph IV certification for US Patent No. 6,515,117 that claims the Dapagliflozin compound. The US District Court for the District of Delaware has scheduled a trial in February 2021 regarding Zydus Cadila’s patent challenge.

The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.

The group now has 311 approvals and has so far filed over 390 ANDAs since the commencement of the filing process in FY 2003-04.