USFDA gives nod for Sevelamer HCL tablets

Sevelamer hydrochloride tablets used to control serum phosphorus in patients with chronic kidney disease (CKD) on dialysis

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USFDA Drug product Approval
USFDA Approval

Last Updated on December 31, 2023 by The Health Master

Aurobindo Pharma Ltd said its wholly-owned subsidiary APL Healthcare has received a final approval from the US health regulator for generic Sevelamer hydrochloride tablets.

Sevelamer hydrochloride tablet is used to control serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.

The approval granted by the US Food & Drug Administration (USFDA) to manufacture and market Sevelamer hydrochloride is for tablets of strengths 400 mg and 800 mg, Aurobindo Pharma said in a regulatory filing.

These tablets are bioequivalent and therapeutically equivalent to the reference listed drug Renagel tablets, 400 mg and 800 mg of Genzyme Corporation, it added.

The approved product has an estimated market size of around USD 37 million for the twelve months ending May 2023, the company said citing IQVIA data.

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