Aurobindo Pharma Ltd has received final approval from the US Food & Drug Administration (USFDA) to manufacture Sevelamer Carbonate oral suspension.
Sevelamer Carbonate oral suspension is a therapeutic equivalent generic version of Genzyme’s Renvela oral suspension.
The product is being launched immediately. It is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis, the Hyderabad-based Aurobindo said in release.
The approved product has an estimated market size of $140 million for the 12 months ending April 2017, according to IMS.