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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:  04/26/2005
 
Trade Name:  Gemzar
 
Generic Name or Proper Name (*):  gemcitabine
 
Indications Studied:  Refractory leukemia
 
Label Changes Summary:  * Effectiveness in pediatric patients has not been demonstrated * Phase 1 trial in pediatric patients with refractory leukemia demonstrated a maximum tolerated dose; however, no meaningful clinical activity observed in a Phase 2 trial of gemcitabine in 22 patients with relapsed acute lymphoblastic leukemia and 10 patients with acute myelogenous leukemia * Toxicities observed were similar to those reported in adults
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Lilly
 
Pediatric Exclusivity Granted Date:  01/27/2005
 
NNPS:  FALSE
 
Therapeutic Category:  Antineoplastic
 
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