Lupin receives USFDA approval for Colesevelam Hydrochloride Tablets

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Capital Market
Last Updated : Dec 19 2020 | 1:16 PM IST
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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First Published: Dec 19 2020 | 1:04 PM IST

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