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Aurobindo Pharma receives US FDA approval for sevelamer oral suspension

Product is indicated to control serum phosphorus in patients with chronic kidney disease on dialysis

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Last Updated : Jun 19 2017 | 3:30 PM IST

Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (FDA) to manufacture sevelamer carbonate oral suspension (0.8 gm and 2.4 gm), which is a therapeutic equivalent generic version of Genzyme’s Renvela oral suspension. The company plans to launch the product very soon.

Sevelamer carbonate oral suspension is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The approved product has an estimated market size of $ 140 million for the twelve months ending April 2017, according to IMS.

This is Aurobindo’s 116th ANDA (including 19 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad, used for manufacturing oral products. Aurobindo now has a total of 323 ANDA approvals (288 final approvals including 16 from Aurolife Pharma LLC and 35 tentative approvals) from US FDA.