Natco Pharma Ltd has received final nod from the US Food and Drug Administration (FDA) for Abbreviated New Drug Application (ANDA) for lanthanum carbonate chewable tablets.
The product, as the first generic, will be launched shortly in the US market. The drug is the generic equivalent of Shire Development LLC’s Fosrenol and is indicated to reduce serum phosphate in patients with End Stage Renal Disease (ESRD).
Fosrenol chewable tablets has US sales of $122.4 million (IMS MAT June 2017). Lupin and Natco had entered into an agreement on September 01, 2008 to jointly commercialise generic equivalents of Fosrenol, according to a release.
Natco’s scrip closed higher by 5.24 per cent at Rs 739.30 on the BSE.