 "Lupin gets US FDA nod for antibacterial drug azithromycin suspension")
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
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