Drug firm Zydus Cadila on Friday said it has received tentative nod from the US health regulator to market generic Empagliflozin tablets, used for improvement of blood sugar control in adults with 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 tablets, in the strengths of 10 mg and 25 mg, Zydus Cadila said in a statement.
The drug will be manufactured at the group's manufacturing facility at SEZ, Ahmedabad, it added.
The group now has 286 approvals and has so far filed over 386 abbreviated new drug applications (ANDAs) since the commencement of its filing process, Zydus Cadila said.
The medication is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. It is also used to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease, it added.
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