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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:  07/14/2000
 
Trade Name:  Malarone
 
Generic Name or Proper Name (*):  atovaquone/ proguanil
 
Indications Studied:  Treatment of malaria
 
Label Changes Summary:  * Safety and efficacy for treatment of malaria established down to5 kg. * Attributable AE occurring in e 5% of the pediatric patients (5-< 11 kg) was diarrhea (6%) * Malarone tablets may be crushed and mixed with condensed milk just prior to administration for children who may have difficulty swallowing. * The apparent clearance (CL/F) of both atovaquone and proguanil are related to body weight
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Glaxo Wellcome
 
Pediatric Exclusivity Granted Date:  08/06/2003
 
NNPS:  FALSE
 
Therapeutic Category:  Antimalarial
 
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