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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:
11/26/2002
Trade Name:
Strattera
Generic Name or Proper Name (*):
atomoxetine
Indications Studied:
Attention-Deficit Hyperactivity Disorder
Label Changes Summary:
Safety and effectiveness established down to 6 years of age It is unknown whether final adult height or weight is affected by treatment. Patients on long-term treatment should be monitored The effectiveness of atomoxetine beyond 9 weeks and safety beyond 1 year in pediatric patients, has not been systematically evaluated in controlled trials
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Lilly
Pediatric Exclusivity Granted Date:
12/18/2001
NNPS:
FALSE'
Therapeutic Category:
Non-stimulant ADHD treatment
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