NEW DELHI: Sun Pharmaceutical Industries has received final nod from the US health regulator for its generic Metformin Hydrochloride extended release tablets used for treatment of diabetes, and plans to launch them in next few weeks in the American market.
One of the subsidiaries of the company “has received final approval from United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for generic version of Glumetza Metformin Hydrochloride extended release tablets,” Sun Pharma said in a BSE filing.
The approval is for the tablets in the strengths of 500 mg and 1000 mg, it added.
Company’s tablets are generic versions of Santarus Inc’s Glumetza tablets, Sun Pharma said.
“As per IMS MAT June 2016, these tablets have annual sales of approximately USD 1.2 billion in the US,” it added.
The commercial launch of these tablets in the US is expected over the next few weeks, it said.
Glumetza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.