Lupin gets USFDA nod for Sevelamer tablets used for treatment of kidney disease
PremiumSevelamer Hydrochloride Tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis
Drug maker Lupin on Thursday said it has received approval from the US health regulator to market Sevelamer Hydrochloride tablets, which is used to control serum phosphorus in patients with chronic kidney disease, in the American market.
The company has received approval from the US Food and Drug Administration (USFDA) to market its generic version in strengths of 400 mg and 800 mg, Lupin said in a regulatory filing.
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The Mumbai-based drug firm's product is the generic version of Genzyme Corporation's Renagel.
The product will be manufactured at the company's Nagpur plant, Lupin noted.
Sevelamer Hydrochloride Tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.
As per IQVIA March data, Sevelamer Hydrochloride tablets had estimated annual sales of $80 million in the US.
This story has been published from a wire agency feed without modifications to the text.
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