Lupin bags USFDA nod for generic equivalent of Renvela Tablets
Mumbai, Baltimore: Drugmaker, Lupin Limited, announced today that the company has received approval for its Sevelamer Carbonate Tablets, 800 mg, from the United States Food and Drug Administration(USFDA).
The product is a generic equivalent of Renvela Tablets, 800 mg, of Genzyme Corporation.
Sevelamer Carbonate Tablets, 800 mg, are indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease on dialysis.
Sevelamer Carbonate Tablets (RLD: Renvela) had estimated annual sales of USD 348 million in the U.S. (IQVIA MAT September 2020).
Lupin Limited is a global pharmaceutical company based in Mumbai, Maharashtra, India.
The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle-East regions.