Lupin gets tentative USFDA nod for empagliflozin and metformin hydrochloride ER tablets

Lupin has received tentative approval for its Empagliflozin and Metformin Hydrochloride ExtendedRelease (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, 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 ER Tablets (RLD: Synjardy XR) had estimated annual sales of $357 million in the US. (IQVIA MAT November 2020).