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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:
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
BPCA(B):
B
Sponsor:
Bristol-Myers Squibb
Pediatric Exclusivity Granted Date:
04/05/2011
NNPS:
FALSE'
Therapeutic Category:
Antineoplastic
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