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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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