FDA gives Lupin tentative nod for generic Jardiance

The Food and Drug Administration has given tentative clearance for Lupin’s empagliflozin tablets, in dosage strengths of 10 mg and 25 mg. 

The generic of Boehringer Ingelheim's Jardiance tablets will be available in 10- and 25-mg. tablets and is indicated as a product for glycemic control in adults with Type 2 diabetes as an adjunct to diet and exercise.

Empagliflozin tablets, 10 mg and 25 mg had a market value of roughly $4.4 billion, according to IQVIA March 2020 data.