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Glenmark gets tentative nod from USFDA for generic type-2 diabetes tablets

The product is a generic version of AstraZeneca AB's Farxiga tablets

Press Trust of India  |  New Delhi 

Glenmark Pharmaceuticals
Glenmark Pharmaceuticals

Drug firm 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.

"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," 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 $1.8 billion.

Farxiga tablets are used as an adjunct to diet and exercise to improve glycemic control in adults with 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 were trading at Rs 194 per scrip on the BSE, down 7.84 per cent from their previous close.

First Published: Mon, March 23 2020. 13:41 IST
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