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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
BPCA(B):
B
Sponsor:
Forest Laboratories
Pediatric Exclusivity Granted Date:
07/12/2002
NNPS:
FALSE'
Therapeutic Category:
Antidepressant
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