US FDA approves Ranbaxy's generic version of GlaxoSmithKline's Ceftin for US sales
06 February 2008
Ranbaxy Laboratories Ltd has received approval from the US Food and Drug Administration to manufacture and market cefuroxime axetil for oral suspension USP, 125 mg / 5mL and 250 mg / 5mL, which will be the first generic formulation on the market.
The office of generic drugs, US Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Ceftin by GlaxoSmithKline. The total annual market sales for cefuroxime axetil suspension were $28.7 million (Source: IMS - MAT: December 2007).
Cefuroxime axetil suspension is indicated for the treatment of paediatric patients between three months and 12 years with mild to moderate infections caused by susceptible strains of the designated microorganisms in pharyngitis / tonsillitis, acute bacterial otitis media and impetigo.
"Ranbaxy is pleased to receive this approval for Cefuroxime Axetil Suspension that now allows us to be the only generic Company to offer both dosage forms for a product that is highly prescribed," said Jim Meehan, vice president of sales and distribution, Ranbaxy Pharmaceuticals Inc a wholly owned subsidiary of Ranbaxy Laboratories Ltd.
"We will offer cefuroxime axetil suspension as liquid intended primarily for children that will ease in the administration of this anti-infective. This product will further expand our product portfolio of affordable generic alternatives and will be launched immediately to all classes of trade."