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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:  11/29/2007
Trade Name:  Diovan
Generic Name or Proper Name (*):  valsartan
Indications Studied:  Hypertension
Label Changes Summary:  * Labeling for 6-16 years of age * Not recommended for pediatric patients less than 6 years due to safety findings possibly related to treatment or with glomerular filtration rate < 30mL/min/1.73m2 * Information on dose, clinical studies in 1-16 years and pharmacokinetics * No relevant differences were identified between adverse experience profile for pediatric patients and that previously reported for adult patients * Information on preparation of a suspension
Product Labeling:  Labeling  Opens a new window
Sponsor:  Novartis
Pediatric Exclusivity Granted Date:  08/08/2007
Therapeutic Category:  Antihypertensive