Glenmark gets USFDA approval for Dapagliflozin tablets

Glenmark Pharmaceuticals Inc., USA receives tentative approval from United States Food & Drug Administration (USFDA) for Dapagliflozin tablets, 5 mg and 10 mg, the generic version of Farxiga tablets, 5 mg and 10 mg, of AstraZeneca AB.

According to IQVIATM sales data for the 12-month period ending January 2020, the Farxiga tablets, 5 mg and 10 mg achieved annual sales of approximately $1.8 billion.

Dapagliflozin is used along with diet and exercise and sometimes with other medications, to lower blood sugar levels in patients with type 2 diabetes (condition in which blood sugar is too high as the body does not produce or use insulin normally). It lowers blood sugar by causing the kidneys to get rid of more glucose in the urine.

Glenmark’s current portfolio consists of 165 products authorised for distribution in US market place and 45 ANDA’s pending approval with USFDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

On Monday, the stock of Glenmark Pharma slipped 8.6 per cent to Rs 192.30 from its previous close of Rs 210.50 on BSE.