• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

  • Print
  • Share
  • E-mail
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
Sponsor:  Bristol-Myers Squibb
Pediatric Exclusivity Granted Date:  05/22/2000
Therapeutic Category:  Antianxiety