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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
Sponsor:  Sanofi-Synthelabo
Pediatric Exclusivity Granted Date:  09/16/2004
Therapeutic Category:  Antihypertensive