Pharma major Lupin on Tuesday, November 21, announced that it has received tentative approval from the United States Food and Drug Administration for its abbreviated new drug application for Dapagliflozin Tablets. The tablets are used to treat type 2 diabetes.

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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.

In another exchange filing, the global pharma major said that it has received the USFDA approval for its Abbreviated New Drug Application for Pitavastatin Tablets, 1 mg, 2 mg, and 4 mg, to market a generic equivalent of Livalo Tablets, 1 mg, 2 mg, and 4 mg, of Kowa Company Limited.

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Pitavastatin Tablets are used to lower low-density lipoprotein cholesterol in adults with hyperlipidemia, and adults and pediatric patients (8 years and above) with heterozygous familial hypercholesterolemia (HeFH).

Lupin said that, Pitavastatin Tablets had estimated annual sales of $298 million in the US (IQVIA MAT September 2023).

The shares of Lupin ended over 2% higher in the trade today, ending higher for fourth straight session. The stock has gained in the five out of the last 10 trading sessions. The shares have jumped 58% in the past six months, and 67% in 2023 so far.

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