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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  01/23/2008
 
Trade Name:  Moxatag
 
Generic Name or Proper Name (*):  amoxicillin
 
Indications Studied:  Use for tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes patients 12 years of age and older
 
Label Changes Summary:  * Safety and effectiveness in pediatric patients younger than 12 years have not been established * One clinical study evaluated safety and effectiveness in pediatric patients 12 years of age and older with no significant differences in treatment response or adverse reactions between adults and children * A prospective study of 51 children suggested that overdosages of less than 250 mg/kg are not associated with significant clinical symptoms and do not require gastric emptying * Waiver of studies in children ages 0 to less than two years because too few children have the disease * New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Middlebrook Pharmaceuticals
 
NNPS:  FALSE
 
Therapeutic Category:  Antibiotic
 
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