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Lupin gets US FDA approval for Colesevelam Hydrochloride Tablets

expresspharmaDecember 21, 2020

Tag: lupin , FDA , LDL-C , Colesevelam Hydrochloride Tablets , Welchol

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).


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