Shares of Lupin hit a 52-week high of Rs 1.224.90 on 8 November after the company announced that it had received tentative approval from USFDA (the United States Food and Drug Administration) for its two drugs.

In its regulatory filing, the company said that it had received tentative approval for its ANDA (abbreviated new drug application) Canagliflozin and Metformin Hydrochloride Extended-Release Tablets, 50 mg/500 mg, 50 mg/1,000 mg, 150 mg/500 mg, and 150 mg/1,000 mg to market the drug, which is a generic equivalent of Janssen Pharmaceuticals, Inc’s Invokamet XR Tablets, 50 mg/500 mg, 50 mg/1,000 mg, 150 mg/500 mg, and 150 mg/1,000 mg.

The products are said to be manufactured at the company’s Pithampur Facility in India.

Canagliflozin and Metformin Hydrochloride Extended-Release Tablets are used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Canagliflozin is said to reduce the risk of major cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.

It also reduces the risk of end-stage kidney disease, cardiovascular death, doubling of serum creatine, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day.

At 3:00 pm, the shares of Lupin were trading 1.62% higher at Rs 1,209 on NSE.