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Lupin gets USFDA nod for generic product

Drug firm Lupin on Saturday said it has received approval from the US health regulator to market Sevelamer Carbonate for Oral Suspension, used in the control of serum phosphorus with chronic kidney disease (CKD) on dialysis.

 


The company has received approval from the United States Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) Sevelamer Carbonate for Oral Suspension in the American market, Lupin said in a statement.

This product will be manufactured at the company’s Goa facility, it added.

As per IQVIA MAT September 2021 data, Sevelamer Carbonate for Oral Suspension had estimated annual sales of USD 51.7 million in the US.