Zydus Cadila gets USFDA nod for diabetes drug Dapagliflozin
Ahmedabad: Drugmaker, Zydus Cadila, has recently announced that the company has received tentative approval from the US Food & Drug Administration (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 hospitalization 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.
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