Lupin gains tentative USFDA nod for Sitagliptin and Metformin Hydrochloride Tablets
Sitagliptin and Metformin Hydrochloride tablets to market a generic equivalent of Janumet tablets of Merck Sharp & Dohme
Lupin received tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Sitagliptin and Metformin Hydrochloride Tablets, 50 mg/500 mg and 50 mg/1000 mg, to market a generic equivalent of Janumet Tablets, 50 mg/500 mg and 50 mg/1000 mg of Merck Sharp & Dohme. This product will be manufactured at Lupin’s Pithampur facility in India.
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 $ 1,145 million in the US (IQVIA MAT September 2024).
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