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
Pediatric Studies Characteristics - Detail
FDA Home
Pediatrics
Pediatric Studies Characteristics
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.
Approval Date:
12/24/2009
Trade Name:
Famvir
Generic or Proper Name (*):
famciclovir
Indications Studied:
Treatment of children 1 month 12 years of age w/ herpes simplex (HSV) & 1 12 years w/ varicella zoster (VSV)
Therapeutic Category:
Antiviral
Ages Studied:
1 month - <1 year
Study #:
3
Study Type:
Safety/Pharmacokinetic
Study Design:
Open label/Population Pharmacokinetic
No Patients:
18
No Centers:
10
No Countries:
3
BPCA(B), PREA(P):
B, P
Asian:
0
Black:
5
Other:
5
White:
8
Native Hawaiian or Pacific Islander:
0
American Indian/Alaska Native:
0
Hispanic/Latino:
0
Non-Hispanic/Non Latino:
0
-
-