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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:  10/16/2014
 
Trade Name:  Cymbalta
 
Generic Name or Proper Name (*):  duloxetine hydrochloride
 
Indications Studied:  Generalized Anxiety Disorder
 
Label Changes Summary:  *The safety and efficacy for GAD in 7 to 17 years of age was demonstrated in one 10-week, placebo-controlled trial (n=272) *Safety and effectiveness in pediatric patients less than 7 years have not been established. *The most frequently observed ARs in the pediatric trials included nausea, headache, weight reduction, and abdominal pain *Weight and height should be regularly monitored in children and adolescents treated with duloxetine *The average steady-state duloxetine concentration was about 30% lower in children and adolescents relative to adults
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Lilly
 
Therapeutic Category:  Antidepressant
 
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