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Industry: Email Alert RSS FeedAugmentin 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.
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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.
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