FDA gives Lupin tentative nod for generic Janumet
Sitagliptin and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Lupin has received tentative approval from the Food and Drug Administration for sitagliptin and metformin hydrochloride tablets, 50 mg/500 mg and 50 mg/1000 mg, which is a generic of Merck Sharp & Dohme’s Janumet.
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.
This product will be manufactured at Lupin’s Pithampur facility in India.
[Read more: Lupin receives FDA OK for generic Banzel]
The product had a market value of roughly $1.1 billion, per IQVIA September 2024 data.