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06/21/2021

Lupin obtains FDA OK for generic Renagel

Lupin received approval for sevelamer hydrochloride tablets, which are indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis.
Sandra Levy
Senior Editor
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Lupin has received the Food and Drug Administration’s approval for sevelamer hydrochloride tablets in dosage strengths of 400 mg and 800 mg.

The product, a generic of Genzyme’s Renagel, is indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis.

Sevelamer hydrochloride tablets had a market value of roughly $80 million, according to March 2021 IQVIA data.

Lupin's medication will be manufactured at Lupin’s facility in Nagpur, India.

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