New Delhi: Glenmark Pharma said it has received final approval from the US health regulator for Colesevelam Hydrochloride tablets, 625 mg, the generic version of Daiichi Sankyo’s Welchol tablets, 625 mg.
“Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Colesevelam Hydrochloride tablets, 625 mg,” the company said in a BSE filing today.
The company said it has already commenced supplies of the product to the US market.
Quoting IQVIA sales data for the 12-month period ending March 2018, Glenmark Pharma said the Welchol tablets, 625 mg, achieved annual sales of approximately USD 519.9 million.
The company’s current portfolio consists of 135 products authorized for distribution in the US market and 62 abbreviated new drug applications (ANDAs) pending approval with the USFDA, it added.