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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
BPCA(B):
B
Sponsor:
Parke-Davis
Pediatric Exclusivity Granted Date:
02/02/2000
NNPS:
FALSE'
Therapeutic Category:
Anticonvulsant
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