Drug firm Aurobindo Pharma has received final approval from the USFDA to manufacture and market Sevelamer Carbonate tablets in the American market. The tablets are indicated for control of serum phosphorus in patients with chronic kidney disease on dialysis. “The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture Sevelamer Carbonate tablets 800 mg,” Aurobindo Pharma said in a BSE filing today.
This product, a therapeutic equivalent generic version of Genzyme’s Renvela tablets, is being launched immediately. The approved product has an estimated market size of USD 1.9 billion for the 12 months to May 2017, according to IMS. Aurobindo Pharma has a total of 331 ANDA approvals (294 final nod, including 16 from Aurolife Pharma LLC and 37 tentative approvals) from the US. The stock was trading 5.59 per cent higher at Rs 774.75 on the BSE in the morning trade.