Wednesday, 19 September 2018

Glenmark Pharma gets USFDA nod for Colesevelam Hydrochloride tablets

21 May 2018 | News

Colesevelam Hydrochloride tablets is generic version of Welchol tablets

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.

Colesevelam hydrochloride is a lipid-lowering and glucose-lowering agent used to lower "bad" cholesterol in the blood. Welchol is sometimes used together with other cholesterol-lowering medications. It is also used to improve glycemic control in people with type 2 diabetes.

"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.

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