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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:  03/19/2009
 
Trade Name:  Lexapro
 
Generic Name or Proper Name (*):  escitalopram oxalate
 
Indications Studied:  Major depressive disorder in adolescents
 
Label Changes Summary:  * Safety and effectiveness have been established in adolescents 12 to 17 years for the treatment of MDD. Maintenance efficacy is supported from extrapolation of data from adult studies along with comparisons with racemic citalopram pharmacokinetic parameters in adults and adolescents. * Safety and effectiveness have not been established in pediatric patients <12 years with MDD * Safety and effectiveness have not been established in pediatric patients less than 18 years of age with Generalized Anxiety Disorder * Adverse events generally similar to those observed in adults * Information on dosing, adverse events, PK parameters, and clinical studies * Patient population altered
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Forest Laboratories
 
Pediatric Exclusivity Granted Date:  07/12/2002
 
NNPS:  FALSE
 
Therapeutic Category:  Antidepressant
 
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