Lupin announced today that it has received approval for its Colesevelam Hydrochloride Tablets, 625 mg, from the United States Food and Drug
Administration (U.S. FDA), to market a generic equivalent of Welchol
Tablets, 625 mg, of Daiichi Sankyo, Inc.
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 USD 159 million in the U.S. (IQVIA MAT September 2020).
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