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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:  05/30/2013
 
Trade Name:  Kepivance
 
Generic Name or Proper Name (*):  palifermin
 
Indications Studied:  Acute leukemias undergoing myeloablative therapy and allogeneic hematopoietic stem cell transplant
 
Label Changes Summary:  * Use in pediatric patients ages 1 - 16 years is supported by evidence from adequate and well-controlled studies in adults and a phase 1 study that included 27 pediatric patients with acute leukemia undergoing hematopoietic stem cell transplant * Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Quintiles, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Immunologic agent
 
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