Lupin gets USFDA nod for generic equivalent of Welchol Tablets
Mumbai, Baltimore: Pharma major, Lupin Limited, has recently announced that the company has received approval for its Colesevelam Hydrochloride Tablets, 625 mg, from the United States Food and Drug Administration (USFDA), 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).
The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle-East regions.