Augmentin XR gets nix from FDA

Drug Store News, Jan 21, 2002

FDA said it would not approve GlaxoSmithKline's antibiotic candidate, Augmentin XR extended release tablets (amoxicillin/clavulanate potassium 100 mg/62.5 mg). The agency said it needed "additional bacteriologic efficacy data" for the new proposed formulation in patients with respiratory tract infections due to penicillin-resistant Streptococcus pneumonia.

GSK said it will work with the FDA toward receiving approval for Augmentin XR Extended Release tablets. FDA's ruling does not affect the marketing of the original Augmentin antibiotic.