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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:  08/01/2003
 
Trade Name:  Fludara
 
Generic Name or Proper Name (*):  fludarabine
 
Indications Studied:  Refractory acute leukemia and solid tumors
 
Label Changes Summary:  * Fludarabine was evaluated in 62 pediatric patients and the data were insufficient to establish efficacy in any childhood malignancy
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Berlex
 
Pediatric Exclusivity Granted Date:  04/03/2003
 
NNPS:  FALSE
 
Therapeutic Category:  Antineoplastic
 
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