East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Sevelamer Carbonate Tablets, 800 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Sevelamer Carbonate Tablets, 800 mg to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug Renvela®.
Sevelamer Carbonate is a phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease.
The product has an estimated market size of $1.892B for the twelve months ending May 2017 according to IMS*.
Sevelamer Carbonate Tablets, 800 mg. represent the latest addition to Aurobindo’s broad line of vertically integrated generic pharmaceuticals. Aurobindo’s product portfolio consists of 277 final approvals, including 37 tentative approvals, and 16 approved products from Aurolife. There are 105 additional products on file with U.S. FDA.
* IMS National Sales Perspectives: Retail and Non-Retail MAT April 2017