Zydus Lifesciences gets USFDA nod for generic diabetes drug.
New Delhi: 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 USD 10,486.9 million in the US.
Zydus shares on Wednesday ended 0.23 per cent up at Rs 905 apiece on BSE.
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 USD 10,486.9 million in the US.
Zydus shares on Wednesday ended 0.23 per cent up at Rs 905 apiece on BSE.
