Glenmark Pharmaceuticals on Monday said it has received final approval from the US health regulator for Sevelamer Hydrochloride tablets, used to control serum phosphorus in patients with chronic kidney disease on dialysis.
The approved product is a generic version of Genzyme Corporation’s Renagel tablets.
“Glenmark Pharmaceuticals Inc, USA (Glenmark) has been granted final approval by the United States Food and Drug Administration (USFDA) for Sevelamer Hydrochloride tablets in the strengths of 400 mg and 800 mg,” the company said in a BSE filing.
For the 12 months to December 2018, Renagel tablets market achieved annual sales of approximately USD 102.1 million, Glenmark said, citing IQVIA sales data.
The company’s current portfolio consists of 149 products authorised for distribution at the US marketplace and 53 Abbreviated New Drug Applications (ANDAs) pending approval with the USFDA.