Zydus Cadila gets tentative nod from US health regulator to market type-2 diabetes drug

Drug firm Zydus Cadila on Saturday said it has received tentative nod from the US health regulator to market generic Empagliflozin and Metformin Hydrochloride tablets, used for management of type-2 diabetes, in the American market. 

The company has received tentative approval from the United States Food and Drug Administration (USFDA) to market Empagliflozin and Metformin Hydrochloride tablets in the strengths of 5 mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, and 12.5 mg/1000 mg, Zydus Cadila said in a statement.

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The product will be manufactured at the group's formulations manufacturing facility at SEZ in Ahmedabad, it added.

This medication is used with a proper diet and exercise programme to control high blood sugar in people with type-2 diabetes, Zydus Cadila said.

The group now has 289 approvals and has so far filed over 386?abbreviated new drug applications (ANDAs) since the commencement of its filing process, it added.