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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:  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  Opens a new window
Sponsor:  Lilly
Pediatric Exclusivity Granted Date:  12/18/2001
Therapeutic Category:  Non-stimulant ADHD treatment