Drug firm Zydus Cadila on Thursday said it has received tentative nod from the US health regulator to market generic Sitagliptin and Metformin Hydrochloride extended-release tablets used for controlling blood sugar levels.
The company has received the tentative approval from the United States Food and Drug Administration (USFDA) to market Sitagliptin and Metformin Hydrochloride extended-release tablets in the strength of 50 mg/500 mg, 50 mg/1,000 mg and 100 mg/1,000 mg
The product is the generic version of Janumet XR tablets, it added.
The tablets will be manufactured at the group's formulations manufacturing facility at SEZ, Ahmedabad, Zydus Cadila said.
The product contains two oral anti-diabetic medications used in the management of type 2 diabetes, it added.
The group now has 255 approvals and has so far filed over 350 abbreviated new drug applications (ANDAs) since the commencement of its filing process, Zydus Cadila said.