Drug firm Zydus Cadila has received final nod from the United States Food and Drug Administration (USFDA) to market generic Sevelamer Carbonate tablets, indicated for control of phosphorus in people with chronic kidney disease who are on dialysis, in the American market.
The company has received final approval from the United States Food and Drug Administration (USFDA) to market Sevelamer Carbonate tablets in the strength of 800 mg, Zydus Cadila said in a filing to the BSE.
The drug will be manufactured at the group’s formulation manufacturing facility at SEZ, Ahmedabad, it added. The drug is used to control phosphorus levels in people with chronic kidney disease who are on dialysis.
It helps prevent hypocalcemia (low levels of calcium in the body) caused by elevated phosphorus, Zydus Cadila said. The group now has 296 approvals and has so far filed over 390 abbreviated new drug applications (ANDAs) since the commencement of its filing process, it said.
