Lupin obtains tentative OK for generic Qtern

Lupin has received tentative approval from the Food and Drug Administration for Dapagliflozin and Saxagliptin Tablets, 5 mg/5 mg and 10 mg/5 mg, which is the generic of AstraZeneca’s Qtern. 

Dapagliflozin and Saxagliptin Tablets 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]

Dapagliflozin and Saxagliptin Tablets had a market value of roughly $5 million, per IQVIA  November 2023 data.

[Read more: Lupin receives FDA nod for 3 generics]