Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
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
 
BPCA(B):  B
 
Sponsor:  Novartis
 
Pediatric Exclusivity Granted Date:  08/08/2007
 
NNPS:  FALSE'
 
Therapeutic Category:  Antihypertensive
 
-
-