Lupin on Thursday 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 rng/1000 mg, from the United States Food and Drug Administration.
The company will market a generic equivalent of Synjardy6 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.
Lupin will manufacture the product from its Nagpur facility in India.
According to the regulatory filing, 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.
Further, Lupin stated that Empagliflozin and Metformin Hydrochloride ER Tablets (RLD: SynjardytXR) had estimated annual sales of USD 357 million in the U.S. (IQVIA MAT November 2020).
On Sensex, Lupin stock ended at Rs1022 per piece up Rs21.40 or 2.14%.