Global pharma major Lupin Limited on Thursday announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Sitagliptin and Metformin Hydrochloride Tablets, 50 mg/500 mg and 50 mg/1000 mg.
According to the company’s statement, the approval has been granted to market a generic equivalent of Janumet Tablets, 50 mg/500 mg and 50 mg/1000 mg of Merck Sharp & Dohme LLC. This product will be manufactured at Lupin’s Pithampur facility in India.
The company stated that Sitagliptin and Metformin Hydrochloride Tablets, 50 mg/500 mg and 50 mg/1000 mg are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Sitagliptin and Metformin Hydrochloride Tablets, 50 mg/500 mg and 50 mg/1000 mg (RLD Janumet Tablets) had an estimated annual sale of USD 1,145 million in the U.S. (IQVIA MAT September 2024).
