Dr Reddy's Laboratories Limited announced on Tuesday that it has launched cholesterol lowering Colesevelam HCl Tablets, a therapeutic equivalent generic version of Welchol Tablets, in the US market.
The company's abbreviated new drug application (ANDA) for this product was recently approved by the US Food and Drug Administration (US FDA).
The Welchol brand, which is a registered trademark of Daiichi Sankyo, Inc, and generics had US sales of approximately $471 million for the most recent twelve months ending in August 2018, the company said, while quoting the IMS Health data.
Dr Reddy's Colesevelam Hydrochloride tablets is available in 625 mg with 180-count bottle size, according to the press release.
Other companies, namely Alkem Labs, Glenmark Pharmaceuticals and Impax Labs were also granted product approval to manufacture and market Colesevelam HCl tablets by the US drug regulator.