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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:  02/09/2012
Trade Name:  Famvir
Generic Name or Proper Name (*):  famciclovir
Indications Studied:  Recurrent herpes labialis
Label Changes Summary:  "Efficacy has not been established in pediatric patients for the treatment of recurrent herpes labialis "Information on an open label PK, safety and efficacy study in children 12 to <18 years with recurrent herpes labialis added to Pediatric Use subsection of labeling"Postmarketing study
Product Labeling:  Labeling  Opens a new window
Sponsor:  Novartis
Therapeutic Category:  Antiviral