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GSK gets FDA approval for Augmentin XR Extended Release Tablets

PHILADELPHIA, PA., Sept. 26 -- GlaxoSmithKline announced that Augmentin XR (amoxicillin/clavulanate potassium) Extended Release Tablets have received FDA approval for the treatment of adults with acute bacterial sinusitis (ABS) or community-acquired pneumonia (CAP).

Specifically, Augmentin XR is indicated for the treatment of patients with ABS or CAP confirmed or suspected to be caused by beta-lactamase-producing bacteria such as Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pneumoniae (S. pneumoniae) with reduced susceptibility to penicillin (i.e., penicillin MICs* = 2 mcg/mL).

S. pneumoniae with penicillin MIC >/= 2 mcg/mL are considered resistant to penicillin.

Augmentin XR employs a unique extended release formulation -- bi-layer tablets that provide an immediate release of amoxicillin and clavulanate potassium and an extended release of amoxicillin. This enhanced formulation prolongs the time that the bacterium is exposed to the antibiotic, and promotes coverage of tough-to-treat S. pneumoniae.

Augmentin XR is the first antibiotic to be approved for the treatment of both ABS and CAP caused by strains of this bacterium with reduced penicillin susceptibility (MIC = 2 mcg/mL).

"Years ago, most antibiotics approved for respiratory tract infections were effective," said Michael Benninger, M.D., Chairman of the Department of Otolaryngology -- Head and Neck Surgery -- at Henry Ford Hospital, Detroit, Mich. "But recently, S. pneumoniae resistance to penicillin has increased dramatically -- to about 20 percent nationwide -- making antibiotic selection very important.

"Augmentin XR will be important in physicians' efforts to continue to successfully fight infection, given today's environment of bacterial resistance."

Augmentin XR is a member of the beta-lactam class of antimicrobials and is made up of amoxicillin and clavulanate potassium. Each Augmentin XR Extended Release Tablet contains 1000 mg of amoxicillin and 62.5 mg of clavulanate.

Source: GlaxoSmithKline

For complete prescribing information for Augmentin XR Extended Release Tablets, Augmentin ES-600 or Augmentin, visit  or call 1-888-825-5249.

Posted: September 2002