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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:
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
BPCA(B):
B
Sponsor:
Lilly
Pediatric Exclusivity Granted Date:
01/27/2005
NNPS:
FALSE'
Therapeutic Category:
Antineoplastic
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