Lupin receives approval from U.S. FDA for Pitavastatin Tablets

Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) 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. The product will be manufactured at Lupin's Pithampur facility in India.

Pitavastatin Tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:

- Adults with primary hyperlipidemia.
- Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).

Pitavastatin Tablets (RLD Livalo®) had estimated annual sales of USD 298 million in the U.S. (IQVIA MAT September 2023).

Shares of Lupin Limited was last trading in BSE at Rs. 1198.05 as compared to the previous close of Rs. 1196.30. The total number of shares traded during the day was 132182 in over 3860 trades.

The stock hit an intraday high of Rs. 1216.05 and intraday low of 1192.65. The net turnover during the day was Rs. 158864261.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 Approval USFDA PitavastatinTablets