Zydus Lifesciences gets US FDA approval for generic diabetes drug

Zydus Lifesciences on Wednesday has received approval from the US health regulator to market a generic diabetes drug in the US market.

The company has received tentative approval from the US Food and Drug Administration (USFDA) for Dapagliflozin Tablets in strengths of 5 mg and 10 mg, the drug firm said in a statement.

Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.

The company said the tablets will be manufactured at its formulation manufacturing facility at SEZ, Ahmedabad. As per the industry estimates, Dapagliflozin tablets had annual sales of $10,486.9 million in the US.

 

Zydus shares on Wednesday ended 0.23 per cent up at Rs 905 apiece on BSE.