The Office of Generic Drugs, FDA, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Ceftin by GlaxoSmithKline. Cefuroxime Axetil suspension is indicated for the treatment of pediatric patients 3 months to 12 years of age with mild to moderate infections caused by susceptible strains of the designated microorganisms in the following conditions: pharyngitis or tonsillitis, acute bacterial otitis media and impetigo.
Jim Meehan, vice president of sales and distribution for Ranbaxy Pharmaceuticals, said: “This product will further expand our product portfolio of affordable generic alternatives and will be launched immediately to all classes of trade.”