Lupin gets USFDA nod for generic diabetes drug

The Mumbai-based company has received a tentative approval from the US Food and Drug Administration (USFDA) for its Empagliflozin tablets, in strengths of 10 mg and 25 mg, Lupin said in a statement. The product is a generic version of Boehringer Ingelheim Pharmaceuticals, Inc's Jardiance tablets which are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

New Delhi, Aug 4 (PTI) Drug maker Lupin on Tuesday said it has received approval from the US health regulator to market a generic diabetes drug in America. The Mumbai-based company has received a tentative approval from the US Food and Drug Administration (USFDA) for its Empagliflozin tablets, in strengths of 10 mg and 25 mg, Lupin said in a statement.

The product is a generic version of Boehringer Ingelheim Pharmaceuticals, Inc's Jardiance tablets which are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. As per IQVIA MAT March 2020 data, the drug had an annual sales of around USD 4,368 million in the US.