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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:  06/26/2012
 
Trade Name:  Treanda
 
Generic Name or Proper Name (*):  bendamustine hydrochloride
 
Indications Studied:  Relapsed or refractory acute leukemia
 
Label Changes Summary:  Effectiveness in pediatric patients has not been established Treanda was evaluated in a Phase 1/2 trial in pediatric patients with leukemia The safety profile in pediatric patients was consistent with that seen in adults, and no new safety signals were identified Information on dosing, clinical trials and PK parameters
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
NNPS:  FALSE'
 
Therapeutic Category:  Antineoplastic
 
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