Type 2 diabetes generic medicine manufactured in drug maker Lupin Limited’s Mihan unit in Nagpur will soon be sold in the American markets.
The company has received tentative approval for empagliflozin and metformin hydrochloride extended-release tablets in multiple strengths from the United States Food and Drug Administration (USFDA), Lupin said in a statement on Thursday.
The Mumbai headquartered company’s product is a generic equivalent of Boehringer Ingelheim Pharmaceuticals’ synjardy XR tablets, it added.
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 November 2020 data of IQVIA, formerly Quintiles and IMS Health Inc, an American multinational company serving the combined industries of health information technology and clinical research, empagliflozin and metformin hydrochloride ER tablets had estimated annual sales of $357 million in the US.