Cipla Ltd.

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Cipla’s arm receives final approval for generic Renvela Tablets

Date: 27-10-2017

Cipla’s 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) to market a generic version of Genzyme’s Renvela Tablets, 800 mg. Renvela Tablets had US sales of approximately $1.85 billion for the 12-month period ending August 2017, according to IMS Health.

Sevelamer Carbonate Tablets, 800 mg is a AB-rated generic equivalent to the reference listed drug (RLD), Renvela Tablets, 800 mg of Genzyme Corporation and are indicated for the control of serum phosphorus in adults with chronic kidney disease (CKD) on dialysis.

Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients. For 80 years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries.