Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
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:
10/10/2003
Trade Name:
Denavir Cream
Generic Name or Proper Name (*):
penciclovir
Indications Studied:
Treatment of recurrent herpes labialis (cold sores) in children 12 years of age and older
Label Changes Summary:
Extended indication down from 18 years of age to 12 years of age Effectiveness extrapolated from adult studies Safety study in patients 12-17 years of age Pediatric submission
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Novartis
NNPS:
FALSE'
Therapeutic Category:
Antiviral, topical
-
-