Lupin Limited, global pharmaceutical company, has received tentative approval for its empagliflozin and metformin hydrochloride extended release (ER) tablets, 5 mg/1000 mg, 10 mg/1000 mg, 12.5 mg/1000 mg, and 25 mg/1000 mg, from the United States Food and Drug Administration (FDA), to market a generic equivalent of Synjardy XR tablets, 5 mg/1000 mg, 10 mg/1000 mg, 12.5 mg/1000 mg, and 25 mg/1000 mg, of Boehringer Ingelheim Pharmaceuticals, Inc.The product will be manufactured at Lupin's Nagpur facility in India.Empagliflozin and metformin hydrochloride extended-release (ER) tablets, 5 mg/1000 mg, 10 mg/1000 mg, 12.5 mg/1000 mg, and 25 mg/1000 mg, are indicated as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin hydrochloride is appropriate.Empagliflozin and metformin hydrochloride extended-release tablets had estimated annual sales of US$ 357 million in the US, according to IQVIA MAT November 2020.
