India, April 8 -- Zydus Lifesciences Limited on Tuesday announced that it has received final approval from the US Food and Drug Administration for its Dapagliflozin Tablets in 5 mg and 10 mg strengths, the generic version of Farxiga.
Dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, is used along with diet and exercise to improve glycaemic control in adults with Type 2 Diabetes Mellitus.
With this approval, Zydus is eligible for 180 days of shared generic drug exclusivity in the US market for the said strengths. The product will be manufactured at the company's formulation facility located in the SEZ at Ahmedabad.
According to industry data, dapagliflozin tablets recorded annual sales of approximately $10.2 billion in th...