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EAST WINDSOR, N.J. — Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application sevelamer hydrochloride tablets 400mg and 800mg. Aurobindo Pharma’s sevelamer hydrochloride tablets are an AB-rated generic equivalent to the reference listed drug (RLD), RENAGEL Tablets manufactured by Genzyme Corp.
Sevelamer hydrochloride tablets, are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.
Sevelamer hydrochloride tablets, has an estimated market size of US $36.9 million for the twelve months ending May 2023, as per IQVIA.
