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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
Sponsor:  Genzyme
Pediatric Exclusivity Granted Date:  07/14/2004
Therapeutic Category:  Antineoplastic