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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:  07/19/2001
 
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  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Bristol-Myers Squibb
 
Pediatric Exclusivity Granted Date:  05/22/2000
 
NNPS:  FALSE
 
Therapeutic Category:  Antianxiety
 
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