FDA approves generic pediatric antibiotic

February 14, 2008

The Food and Drug Administration gave the okay to Ranbaxy Laboratories for its pediatric formulation of the generic antibiotic cefuroxime axetil.

The Food and Drug Administration gave the okay to Ranbaxy Laboratories for its pediatric formulation of the generic antibiotic cefuroxime axetil.

The drug, which is also sold as GlaxoSmithKline's Ceftin, is indicated for treatment of mild to moderate pharyngitis/tonsillitis, acute bacterial otitis media, and impetigo in patients 3 months to 12 years old. Two dose sizes have been approved, 125 mg/5 ml and 250 mg/5 ml.