Drug maker Lupin on Thursday said it has received approval from the US health regulator for its Empagliflozin and Metformin Hydrochloride extended-release (ER) tablets, used to treat diabetes, in the American market.
The company has received tentative approval for the product in multiple strengths from the United States Food and Drug Administration (USFDA), Lupin said in a statement.
The Mumbai-based company's product is a generic equivalent of Boehringer Ingelheim Pharmaceuticals' Synjardy XR tablets, it added.
The product will be manufactured at Lupin's Nagpur-based manufacturing facility.
Empagliflozin and Metformin Hydrochloride extended-release (ER) tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus treatment with both empagliflozin and metformin hydrochloride is appropriate.
As per IQVIA MAT November 2020 data, Empagliflozin and Metformin Hydrochloride ER Tablets had estimated annual sales of $357 million in the US.