Lupin gets tentative approval from US FDA for empagliflozin tablets

Lupin has received tentative approval for its empagliflozin tablets, 10 mg and 25 mg, from the United States Food and Drug Administration (US FDA) to market a generic version of Jardiance Tablets, 10 mg and 25 mg, of Boehringer Ingelheim Pharmaceuticals.

Empagliflozin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Empagliflozin Tablets, 10 mg and 25 mg had an annual sales of approximately $4,368 million in the US (IQVIA MAT Mar 2020).