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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
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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  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Genzyme
 
Pediatric Exclusivity Granted Date:  07/14/2004
 
NNPS:  FALSE'
 
Therapeutic Category:  Antineoplastic
 
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