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:
12/28/2004
Trade Name:
Clolar
Generic Name or Proper Name (*):
clofarabine
Indications Studied:
Relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens
Label Changes Summary:
Labeling for patients 1 to 21 years old. This use is based on the induction of complete responses Randomized trials demonstrating increased survival or other clinical benefit have not been conducted Information on dose, PK parameters, and AE profihe
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Genzyme
Pediatric Exclusivity Granted Date:
07/14/2004
NNPS:
FALSE'
Therapeutic Category:
Antineoplastic
-
-