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Sun Pharmaceutical Industries has received final nod from the US health regulator for its generic Metformin Hydrochloride extended release tablets used for the treatment of diabetes.
The company plans to launch them in the 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 1,000 mg, it added.
The 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 $1.2 billion in the US,” it added.
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.
Shares of Sun Pharmaceutical Industries were today trading down by 0.53 per cent at Rs 830.65 on the BSE.
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