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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:  06/29/2010
Trade Name:  Daytrana
Generic Name or Proper Name (*):  methylphenidate
Indications Studied:  ADHD
Label Changes Summary:  * Expanded pediatric indication to include adolescent patients ages13-17 years * The most commonly reported adverse reactions in a trial in patients 13-17 years included appetite decreased, nausea, insomnia, weight decreased, dizziness, abdominal pain, and anorexia. The majority of patients had erythema at the application site * Information on PK parameters, Adverse Event profile and clinical studies
Product Labeling:  Labeling  Opens a new window
Sponsor:  Shire
Therapeutic Category:  CNS Stimulant