Zydus Cadila gets nod from USFDA to market diabetes drug

The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad, it added. Dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control

New Delhi: Drug firm Zydus Cadila on Thursday said it has received tentative nod from the US health regulator to market generic Dapagliflozin tablets, used for treatment of type 2 diabetes in adults, in the American market. The company has received tentative approval from the United States Food and Drug Administration (USFDA) to market Dapagliflozin tablets in the strengths of 5 mg and 10 mg, Zydus Cadila said in a statement.

The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad, it added. Dapagliflozin is 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 said.

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The group now has 311 approvals and has so far filed over 390 abbreviated new drug applications (ANDAs) since the commencement of its filing process, it added. Shares of Cadila Healthcare, the listed entity of the group, were trading 1.66 per cent lower at Rs 411.50 per scrip on the BSE.