Lupin Secures US Regulator Approval For Diabetes Drug

Lupin stated that its abbreviated new drug application for Dapagliflozin Tablets has gained preliminary clearance from the US Food and Drug Administration. The medications are prescribed to patients with type 2 diabetes.

The company said that the product will be manufactured at Lupin's Pithampur facility. Dapagliflozin Tablets had estimated annual sales of $7,282 million in the US (IQVIA MAT September 2023), the company said in a exchange filing, as per cnbctv18. 

In another exchange filing, the global pharma giant stated that it has got USFDA clearance for its Abbreviated New Drug Application for Pitavastatin Tablets, 1 mg, 2 mg, and 4 mg, to sell a generic counterpart of Kowa Company Limited's Livalo Tablets, 1 mg, 2 mg, and 4 mg.

Pitavastatin Tablets are used to treat hyperlipidemia in adults, as well as adults and pediatric patients (8 years and older) with heterozygous familial hypercholesterolemia (HeFH).

Pitavastatin Tablets had a projected annual sales of $298 million in the United States, according to Lupin (IQVIA MAT September 2023).

Lupin shares rose more than 2% in trading Thursday, marking the fourth consecutive session of gains. The stock has risen in five of the past ten trading sessions. The stock has risen 58% in the last six months and 67% in 2023.

Lupin Limited is a Mumbai-based Indian multinational pharmaceutical corporation. It is one among the world's largest generic pharmaceutical firms in terms of revenue. Paediatrics, cardiovascular, anti-infectives, diabetology, asthma, and anti-tuberculosis are among the company's primary emphasis areas.