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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:  09/14/2015
 
Trade Name:  Velcade
 
Generic Name or Proper Name (*):  bortezomib
 
Indications Studied:  Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)
 
Label Changes Summary:  *Effectiveness in pediatric patients with relapsed pre-B ALL has not been established. *The activity and safety of Velcade in combination with intensive reinduction chemotherapy was evaluated in pediatric and young adult patients with lymphoid malignancies. There were 140 patients with ALL or LL enrolled and evaluated for safety. *No new safety concerns were observed
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Millennium Pharmaceuticals, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Antineoplastic
 
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