Cipla gets USFDA nod for Generic Renvela Tablets

Cipla gets USFDA nod for Generic Renvela Tablets

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Cipla Ltd, a global pharmaceutical company which uses cuttingedge technology and innovation to meet the everyday needs of all patients, announced that its subsidiary, InvaGen Pharmaceuticals Inc. (collectively Cipla), 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.

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.

Renvela Tablets had US sales of approximately $1.85B for the 12-month period ending August 2017, according to IMS Health. Commercial launch will commence immediately.