Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
A to Z Index
Follow FDA
FDA Voice Blog
Enter Search terms
Most Popular Searches
Home
Food
Drugs
Medical Devices
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Radiation-Emitting Products
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
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
PREA(P):
P
Sponsor:
Novartis
Therapeutic Category:
Antiviral
-
-