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FDA Approves MiddleBrook's Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
Date:1/24/2008

coccal infections, who were compliant with treatment and did not have major protocol violations. Other results from the trial were consistent with the per-protocol population, with MOXATAG therapy demonstrating statistical non-inferiority to the comparator therapy in all primary and secondary endpoints.

Important Safety Information

MOXATAG is indicated for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatric patients 12 years or older.

MOXATAG is contraindicated in patients with known serious hypersensitivity to amoxicillin or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactams.

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. Before initiating therapy with MOXATAG, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, MOXATAG should be discontinued and appropriate therapy instituted.

Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including amoxicillin, and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.

In a controlled U.S. clinical trial, the majority of treatment-emergent adverse reactions were of a mild and transient nature. The most frequently reported advers
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SOURCE MiddleBrook Pharmaceuticals, Inc.
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