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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:  03/16/2006
 
Trade Name:  Avapro
 
Generic Name or Proper Name (*):  irbesartan
 
Indications Studied:  Hypertension
 
Label Changes Summary:  * In a study at a dose up to 4.5 mg/kg once daily, irbesartan did not appear to lower blood pressure effectively in pediatric patients ages 6 to 16 years
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Sanofi-Synthelabo
 
Pediatric Exclusivity Granted Date:  09/16/2004
 
NNPS:  FALSE
 
Therapeutic Category:  Antihypertensive
 
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