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:
05/17/2011
Trade Name:
Faslodex Injection
Generic or Proper Name (*):
fulvestrant
Indications Studied:
Use in girls with progressive precocious puberty associated with McCune-Albright Syndrome
Therapeutic Category:
Estrogen lowering agent
Ages Studied:
< 10 years
Study #:
2
Study Type:
Efficacy/Safety
Study Design:
Open Label
No Patients:
30
No Centers:
15
No Countries:
6
BPCA(B), PREA(P):
B
Asian:
0
Black:
1
Other:
3
White:
26
Unknown:
0
Native Hawaiian or Pacific Islander:
0
American Indian/Alaska Native:
0
Hispanic/Latino:
3
Non-Hispanic/Non Latino:
27
Countries:
US (7 centers), France (3), Germany (2), Italy (1), Russia (1), United Kingdom (1).
-
-