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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
BPCA(B):
B
NNPS:
FALSE'
Therapeutic Category:
Antineoplastic
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