Lupin gets US FDA approval for Colesevelam Hydrochloride Tablets

Lupin has received approval for its Colesevelam Hydrochloride Tablets, 625 mg, from the United States Food and Drug Administration (US FDA), to market a generic equivalent of Welchol Tablets, 625 mg, of Daiichi Sankyo. 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.

• reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH).

Colesevelam Hydrochloride Tablets (RLD: Welchol) had an annual sales of approximately $159 million in the US (IQVIA MAT September 2020).