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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:  11/14/2008
 
Trade Name:  Neulasta
 
Generic Name or Proper Name (*):  Pefilgrastim
 
Indications Studied:  Decrease the incidence of infection in pediatric patients with sarcoma
 
Label Changes Summary:  * Safety and effectiveness in pediatric patients have not been established * Safety and PK were studied in 37 pediatric patients with sarcoma * Information added to Pediatric Use
 
Product Labeling:  http://dailymed.nlm.nih.gov/dailymed/getFile.cfm?id=16131&type=pdf&name=fdfe5d72-6b80-435a-afa4-c5d74dd852ce  Opens a new window
 
PREA(P):  P
 
Sponsor:  Amgen
 
NNPS:  FALSE
 
Therapeutic Category:  Hematopoietic
 
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