Pharma major Lupin Limited (Lupin) and Natco announced the final ANDA approval of Lanthanum Carbonate Chewable Tablets 500 mg (base), 750 mg (base), and 1000 mg (base) from the United States Food and Drug Administration (FDA). The product, as the first generic, will be launched shortly.
Natco’s Lanthanum Carbonate Chewable Tablets 500 mg (base), 750 mg (base), and 1000 mg (base) are generic equivalents of Shire Development LLC’s Fosrenol Chewable Tablets 500 mg, 750 mg and 1000 mg. Lanthanum Carbonate Chewable Tablets 500 mg (base), 750 mg (base), and 1000 mg (base) are indicated to reduce serum phosphate in patients with end stage renal disease (ESRD).