Lupin gets USFDA approval for Sevelamer Carbonate Tablets

They are indicated for the control of serum phosphorus in adults and children six years of age and older with chronic kidney disease on dialysis

Lupin has received approval for its Sevelamer Carbonate Tablets, 800 mg, from the United States Food and Drug Administration (US FDA), to market a generic equivalent of Renvela Tablets, 800 mg, of Genzyme Corporation.

Sevelamer Carbonate Tablets, 800 mg, are indicated for the control of serum phosphorus in adults and children six years of age and older with chronic kidney disease on dialysis.

Sevelamer Carbonate Tablets (RLD: Renvela) had estimated annual sales of $348 million in the US (IQVIA MAT September 2020).

ANDA approvalchronic kidney diseaseLupinserum phosphorusSevelamer Carbonate TabletsUS FDA
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