Ranbaxy gets US OK for generic Ceftin

India's Ranbaxy Laboratories has received manufacturing and marketingapproval from the US Food and Drug Administration for cefuroxime axetil 125mg, 250mg and 500mg tablets, the generic equivalent of GlaxoSmithKline's Ceftin. The Indian company said it is the first to receive approval for such a generic in the USA and is gearing up for launch.

Ceftin is the top-selling oral cephalosporin antibiotic in the USA and Ranbaxy estimates that annual sales are in excess of $254 million in the retail segment alone, not including the hospital market which could take that total above the $300 million mark. The antibiotic is indicated for the treatment of infections caused by susceptible strains of designated organisms in pharyngitis and tonsillitis, as well as infections of the lower respiratory tract, urinary tract and skin.

The approval of Ceftin is expected to provide a real boost to Ranbaxy, with one analyst suggesting that the product could contribute to a doubling of the firm's profits in 2002 from last year to more than $100 million, with sales of up to $50 million for the product in its first year, according to a Reuters report. The firm concurred with this view and said the product could make the USA overtake India as its most important market in terms of revenues.