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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:  09/03/2008
 
Trade Name:  Valtrex
 
Generic Name or Proper Name (*):  valacyclovir
 
Indications Studied:  Chickenpox; active or at risk for herpes virus infection
 
Label Changes Summary:  New indication for treatment of chickenpox in pediatric patients 2 to <18 years based on single-dose pharmacokinetic and multiple-dose safety data from an open-label trial with valacyclovir and supported by safety and extrapolated efficacy data from 3 randomized, double-blind, placebo-controlled trials evaluating oral acyclovir in pediatric patients with chickenpox The efficacy and safety of valacyclovir have not been established in pediatric patients: o <12 years of age with cold sores o<18 years of age with genital herpes o<18 years of age with herpes zoster o<2 years of age with chickenpox, ofor suppressive therapy following neonatal HSV infection Adverse events similar to that of adults Information on PK parameters, AEs, clinical studies, and preparation of an extemporaneous formulation
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  GlaxoSmithKline
 
Pediatric Exclusivity Granted Date:  02/26/2008
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiviral
 
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