Lupin receives tentative approval for Empagliflozin and Metformin Hydrochloride ER tablets

From USFDA

Lupin 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 rng/1000 mg, from the United States Food and Drug Administration, to 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. 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 empaglifiozin and metformin hydrochloride is appropriate.

Empagliflozin and Metformin Hydrochloride ER Tablets (RLD: SynjardytXR) had estimated annual sales of USD 357 million in the U.S. (IQVIA MAT November 2020).

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