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Cipla gets USFDA nod for generic version of Renvela tablets

Press Trust of India  |  New Delhi 

Drug major 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 filing, 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, 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.

of Cipla were trading 1.57 per cent higher at Rs 622 on

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

First Published: Fri, October 27 2017. 10:42 IST