Glenmark receives tentative ANDA approval for Dapagliflozin Tablets

March 23, 2020 | Monday | News

It is the generic version of Farxiga Tablets, 5 mg and 10 mg, of AstraZeneca AB

Source: Pixabay

Glenmark Pharmaceuticals has announced the tentative approval by the 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 market2 achieved annual sales of approximately $1.8 billion.

Glenmark’s current portfolio consists of 165 products authorized for distribution in the U.S. marketplace and 45 ANDA’s pending approval with the USFDA.