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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:  10/31/2014
 
Trade Name:  Lexapro
 
Generic Name or Proper Name (*):  escitalopram oxalate
 
Indications Studied:  Major depressive disorder
 
Label Changes Summary:  *An open-label safety study in 118 children aged 7-11 years who had MDD, did not identify any new safety concerns. Efficacy was not established in this study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Forest
 
Therapeutic Category:  Antidepressant
 
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