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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
Sponsor:  Berlex
Pediatric Exclusivity Granted Date:  04/03/2003
Therapeutic Category:  Antineoplastic