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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:  06/15/2018
 
Trade Name:  LymePak
 
Generic Name or Proper Name (*):  doxycycline hyclate
 
Indications Studied:  Treatment of early Lyme disease due to Borrelia burgdorferi in adults and pediatric patients 8 years of age and older weighing 45 kg and above
 
Label Changes Summary:  *Safety and efficacy have been established in pediatric patients 8 years and older, weighing 45 kg and greater. *Because of the effects of the tetracycline-class of drugs on tooth development, bone development, and growth, use of LymePak in pediatric patients younger than 8 years of age, weighing less than 45 kg is not recommended. *New indication.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Chartwell
 
NNPS:  FALSE
 
Therapeutic Category:  Antibiotic
 
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