Lupin, Natco Pharma get FDA approval for Fosrenol chewable generic

SILVER SPRING, Md. — The Food and Drug Administration has approved Lupin’s and its alliance partner Natco Pharma’s generic of Fosrenol (lanthanum carbonate) chewable tablets, the companies announced Monday. The two companies joined together in 2008 to jointly commercialize this product, which is the first generic of Fosrenol chewable tablets.

“We are very happy to finally be able to launch Lanthanum Carbonate Chewable Tablets in partnership with Natco,” Lupin managing director Nilesh Gupta said. “Lupin’s proven IP capabilities, marketing reach and expertise coupled with Natco’s solid development and manufacturing abilities make a great combination.”

The drug is indicated to reduce serum phosphate in patients with end-stage renal disease. The companies’ generic will be available in 500-, 750-mg and 1000-mg base dosage strengths. For the 12 months ended June 2017, the drug had U.S. sales of $122.4 million, according to QuintilesIMS data.