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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:  http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022249s012lbl.pdf  Opens a new window
 
BPCA(B):  B
 
NNPS:  FALSE
 
Therapeutic Category:  Antineoplastic
 
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