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:
05/17/2011
Trade Name:
Faslodex Injection
Generic Name or Proper Name (*):
fulvestrant
Indications Studied:
Use in girls with progressive precocious puberty associated with McCune-Albright Syndrome
Label Changes Summary:
Efficacy has not been demonstrated in girls with McCune-Albright Syndrome associated with progressive precocious pubertyInformation on dosing, adverse reactions, pharmacokinetics and clinical trial
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
AstraZeneca
Pediatric Exclusivity Granted Date:
02/01/2011
NNPS:
FALSE'
Therapeutic Category:
Estrogen lowering agent
-
-