Lupin Ltd has received the U.S. Food and Drug Administration (USFDA) approval for the company's Abbreviated New Drug Application (ANDA) for cefuroxime axetil 250mg and 500mg tablets, the AB-rated generic equivalent of GlaxoSmithKline's Ceftin tablets. The product patent for the amorphous form of cefuroxime axetil will expire on 29 July 2003.

This ANDA approval is the first finished product approval for Lupin in the US market. Lupin has entered into an agreement with Watson Pharmaceuticals Inc for marketing the product in the U.S. The product will be manufactured at Lupin's manufacturing location at Mandideep, near Bhopal city, in India. The market size of cefuroxime axetil is estimated at US $310 million (December 2002) as per IMS.

Cefuroxime axetil is a semi-synthetic, broad-spectrum cephalosporin antibiotic for oral administration. The tablets are indicated for treating bacterial infections caused by susceptible strains of designated organisms in the pharyngitis and tonsillitis, lower respiratory tract infections, urinary tract infections, and skin infections.