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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:  10/18/2011
 
Trade Name:  Ixempra Kit
 
Generic Name or Proper Name (*):  ixabepilone
 
Indications Studied:  Advanced or refractory solid tumors
 
Label Changes Summary:  * The effectiveness in pediatric patients has not been established * Ixempra was evaluated in one Phase 1 and one Phase 2 trial * Adverse reactions were similar to adults, and no new safety signals were identified
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Bristol-Myers Squibb
 
Pediatric Exclusivity Granted Date:  04/05/2011
 
NNPS:  FALSE
 
Therapeutic Category:  Antineoplastic
 
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