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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:  07/18/2007
 
Trade Name:  Toprol XL
 
Generic Name or Proper Name (*):  metoprolol
 
Indications Studied:  Hypertension
 
Label Changes Summary:  * A study in 144 pediatric hypertensive pediatric patients aged 6 - 16 years did not meet its primary endpoint. However, some study endpoints demonstrated effectiveness * Adverse event profile similar to adults * Safety and effectiveness have not been established in patients < 6 years of age * Information on PK parameters, clinical studies, and dose
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  AstraZeneca
 
Pediatric Exclusivity Granted Date:  07/27/2006
 
NNPS:  FALSE
 
Therapeutic Category:  Antihypertensive
 
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