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India,United States : Marksans Pharma wins USFDA's approval for Metformin Hydrochloride ER tablets.

Marksans Pharma has won approval from the USFDA for Metformin Hydrochloride extended-release (ER) tablets.

The company said the USFDA has approved an Abbreviated New Drug Application (ANDA) for Metformin Hydrochloride extended-release tablets USP 500 mg and 750 mg.

It said,"Metformin Hydrochloride ER tablets USP 500 mg and 750 mg is therapeutically equivalent to the reference listed drug Glucophage XR extended-release tablets 500mg and 750mg respectively of Bristol Myers Squibb (BMS). Metformin Hydrochloride ER tablets are oral anti-hyperglycemic drugs indicated as an adjunct to diet and exercise to improve glycemic control in patients with type-2 diabetes."

The product's annual sale is around USD 230 million.

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Publication:Mena Report
Geographic Code:9INDI
Date:May 4, 2016
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