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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:
07/19/2001
Trade Name:
Buspar
Generic Name or Proper Name (*):
buspirone
Indications Studied:
General Anxiety Disorder
Label Changes Summary:
Safety and effectiveness were not established in patients 6 to 17 years of age for treatment of General Anxiety Disorder at doses recommended for use in adults PK parameters (AUC and Cmax) of buspirone and its active metabolite were found to be equal to or higher in children and adolescents than that of adults
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Bristol-Myers Squibb
Pediatric Exclusivity Granted Date:
05/22/2000
NNPS:
FALSE'
Therapeutic Category:
Antianxiety
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