Drug firm Glenmark Pharmaceuticals on Monday said it has received tentative approval from the US health regulator for generic Dapagliflozin tablets used for treatment of type-2 diabetes.
The product is a generic version of AstraZeneca AB's Farxiga tablets.
"Glenmark Pharmaceuticals Inc USA has been granted tentative approval by the United States Food and Drug Administration (USFDA) for Dapagliflozin tablets, 5 mg and 10 mg," Glenmark said in a filing to BSE.
Citing IQVIA sales data for the 12 month period ending January 2020, the company said Farxiga tablets, brand and all available therapeutic equivalents in strengths of 5 mg and 10 mg, achieved annual sales of approximately USD 1.8 billion.
Farxiga tablets are used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Glenmark's current portfolio consists of 165 products authorised for distribution in the US marketplace and 45 abbreviated new drug applications pending approval with the USFDA, it added.
Shares of Glenmark Pharmaceuticals were trading at Rs 194 per scrip on the BSE, down 7.84 per cent from their previous close.
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