Lupin gets USFDA nod for marketing generic drug to reduce cholesterol

The company has received approval to market its Colesevelam Hydrochloride tablet in the strength of 625 mg, from the United States Food and Drug Administration USFDA, Lupin said in a BSE filing.The product is a generic version of Daiichi Sankyo, Incs Welchol tablets in the same strength, it added.

Drug firm Lupin on Friday said it has received approval from the US health regulator to market generic Colesevelam Hydrochloride tablets used for reducing elevated low-density lipoprotein cholesterol. The company has received approval to market its Colesevelam Hydrochloride tablet in the strength of 625 mg, from the United States Food and Drug Administration (USFDA), Lupin said in a BSE filing.

The product is a generic version of Daiichi Sankyo, Inc's Welchol tablets in the same strength, it added. According to the IQVIA MAT September 2020 data, Colesevelam Hydrochloride tablets had an annual sales of approximately USD 159 million in the US market, the filing said.

Colesevelam Hydrochloride tablets, 625 mg, are indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia and to reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia, it added. Shares of Lupin Ltd closed at Rs 972.20 per scrip on BSE, up 0.19 per cent over previous close.