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:
01/10/2007
Trade Name:
Eloxatin
Generic Name or Proper Name (*):
oxaliplatin
Indications Studied:
Solid tumors
Label Changes Summary:
The effectiveness of oxaliplatin in children has not been established No significant activity observed in 2 Phase I and 2 Phase II trials in 159 patients ages 7 months to 22 years with solid tumors Information on clinical studies and AEs
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Sanofi-Aventis
Pediatric Exclusivity Granted Date:
09/27/2006
NNPS:
FALSE'
Therapeutic Category:
Antineoplastic
-
-