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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, o for 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
Therapeutic Category:  Antiviral