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Aurobindo gets US Food and Drug Administration nod for oral suspension
Aurobindo Pharma on Thursday announced that it has received US FDA nod to make oral suspension used for controlling serum phosphorus in patients with chronic kidney disease on dialysis.
Hyderabad: Aurobindo Pharma on Thursday announced that it has received US FDA nod to make oral suspension used for controlling serum phosphorus in patients with chronic kidney disease on dialysis.
The drug major 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 communiqué to BSE.
“This is the 116th ANDA to be approved out of Unit VII formulation facility in Hyderabad, India used for manufacturing oral products. The drug is a therapeutic equivalent generic version of Genzyme’s Renvela oral suspension,” Aurobindo Pharma said in the filing.
Sevelamer Carbonate oral suspension is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.
