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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:  09/27/2006
Trade Name:  Gleevec
Generic Name or Proper Name (*):  imatinib mesylate
Indications Studied:  Treatment of newly diagnosed pediatric patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
Label Changes Summary:  * Extended age range for the treatment of newly diagnosed CML down to pediatric patients * There are no data in children < 2 years of age * Follow-up in children with newly diagnosed Ph+ chronic phase CML is limited * Information on hematologic toxicities, AE profile, clinical studies and dosing guidelines new for newly diagnosed pediatric patients
Product Labeling:  Labeling  Opens a new window
BPCA(B) and PREA(P):  B, P
Sponsor:  Novartis
Pediatric Exclusivity Granted Date:  06/09/2006
Therapeutic Category:  Antineoplastic