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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:  07/21/2005
 
Trade Name:  Adderall XR
 
Generic Name or Proper Name (*):  amphetamines mixed salts
 
Indications Studied:  ADHD
 
Label Changes Summary:  * Expanded labeling for 13-17 year olds * On a mg/kg body weight basis children 6-12 years have a higher clearance than adolescents or adults. Body weight is the primary determinant * There was not adequate evidence that doses greater than 20 mg/day conferred additional benefit in a placebo-controlled study conducted in adolescents aged 13-17 with ADHD * In a single-dose PK study in adolescents, isolated increases in systolic blood pressure (SBP) were observed in patients receiving 10 mg and 20 mg Adderall XR. Higher single doses were associated with a greater increase in SBP * Sustained increases in blood pressure should be treated with dose reduction and/or appropriate medication * Information on dose, PK parameters, and AE profile
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Shire
 
Pediatric Exclusivity Granted Date:  10/28/2004
 
NNPS:  FALSE
 
Therapeutic Category:  CNS Stimulant
 
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