Zydus Cadila gets tentative nod from USFDA to market type-2 diabetes drug

Drug firm Zydus Cadila on Saturday said it has received a 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. 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 program 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.