Aurobindo Pharma gets USFDA approval for Sevelamer hydrochloride tablets

New Delhi: Aurobindo Pharma on Wednesday said its wholly-owned subsidiary APL Healthcare has received a final approval from the US health regulator for generic Sevelamer hydrochloride tablets used to control serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.

The approval granted by the US Food and 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 $37 million for the twelve months ending May 2023, the company said citing IQVIA data.