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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:  10/12/2000
 
Trade Name:  Neurontin
 
Generic Name or Proper Name (*):  gabapentin
 
Indications Studied:  Adjunctive therapy in the treatment of partial seizures
 
Label Changes Summary:  * Safety and effectiveness established down to 3 years * Neuropsychiatric AE's identified in 3-12 year olds * Oral clearance normalized per body weight increased in children <5 years * Higher doses of gabapentin required in children <5 years
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Parke-Davis
 
Pediatric Exclusivity Granted Date:  02/02/2000
 
NNPS:  FALSE
 
Therapeutic Category:  Anticonvulsant
 
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