Drug major Cipla today said its subsidiary InvaGen Pharmaceuticals Inc has received final approval from the US health regulator for Sevelamer Carbonate tablets, indicated for the control of serum phosphorus in adults with chronic kidney disease (CKD) on dialysis.
In a BSE filing, Cipla said "its subsidiary, InvaGen Pharmaceuticals Inc. has received final approval for its abbreviated new drug application (ANDA) for Sevelamer Carbonate Tablets, 800 mg, from the United States Food and Drug Administration (USFDA)".
The approved product is a generic equivalent to the reference listed drug (RLD), Renvela tablets, 800 mg of Genzyme Corporation, it added.
Quoting IMS Health data, Cipla said Renvela tablets had US sales of approximately USD 1.85 billion for the 12-month period ending August 2017.
The company will commence commercial launch of the product immediately.
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