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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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