Aurobindo Pharma gets USFDA nod for oral suspension
New Delhi: Drug firm Aurobindo Pharma has received USFDA nod to make oral suspension used for controlling 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 oral suspension, 0.8 gm and 2.4 gm, the drug maker said in a BSE filing.
The company's drug is a therapeutic equivalent generic version of Genzyme's Renvela oral suspension, it added.
Sevelamer Carbonate oral suspension is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.
According to IMS April 2017 data, the approved product has an estimated market size of USD 140 million, the company said.
"This is the 116th ANDA (including 19 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad, India used for manufacturing oral products," Aurobindo Pharma added.
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