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).