The USFDA approves the Aurobindo Pharma division's Sevelamer hydrochloride tablets

13 Jul 2023 , 01:53 PM

The US health agency has given the generic Sevelamer hydrochloride tablets used to regulate serum phosphorus in patients with chronic kidney disease (CKD) receiving dialysis its final approval, according to Aurobindo Pharma Ltd.

According to Aurobindo Pharma’s regulatory filing, the US Food & Drug Administration (USFDA) has approved the manufacture and marketing of Sevelamer hydrochloride tablets in strengths of 400 mg and 800 mg.

The 400 mg and 800 mg Renagel pills from Genzyme Corporation are bioequivalent and medically equivalent to these tablets, according to the statement.

According to the business, which cited IQVIA statistics, the approved product’s market size is anticipated to be roughly USD 37 million for the 12 months ending in May 2023.

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