Natco Pharma has received the final approval of Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (USFDA) for Lanthanum Carbonate Chewable Tablets 500 mg (base), 750 mg (base), and 1000 mg (base). The product, as the first generic, will be launched shortly in the USA market.
Natco’s Lanthanum Carbonate strengths mentioned above are generic equivalents of Shire Development LLC’s Fosrenol Chewable Tablets and are indicated to reduce serum phosphate in patients with End Stage Renal Disease (ESRD). Fosrenol Chewable Tablets has US sales of $122.4 million as per IMS MAT June 2017. Lupin and Natco had entered into an agreement on September 01, 2008 to jointly commercialize generic equivalents of Fosrenol Chewable Tablets.
Natco Pharma was promoted as a private company to be in the business of research, developing, manufacturing and marketing of pharmaceutical substances and finished dosage forms for Indian and International markets.
