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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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