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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:
12/06/2019
Trade Name:
Abraxane
Generic Name or Proper Name (*):
paclitaxel
Indications Studied:
Recurrent or refractory pediatric solid tumors
Label Changes Summary:
*Safety and effectiveness in pediatric patients have not been established. *Pharmacokinetics, safety, and antitumor activity were assessed in an open-label, dose escalation, dose expansion study in 96 pediatric patients aged 1.4 to < 17 years with recurrent or refractory pediatric solid tumors. *The maximum tolerated dose (MTD) normalized for body surface area (BSA) was lower in pediatric patients compared to adults. *No new safety signals were observed in pediatric patients across these studies. *Paclitaxel protein-bound exposures normalized by dose were higher in 96 pediatric patients aged 1.4 to < 17 years as compared to those in adults.
BPCA(B):
B
Sponsor:
Abraxis BioScience, L.L.C.
Pediatric Exclusivity Granted Date:
11/08/2019
NNPS:
FALSE
Therapeutic Category:
Antineoplastic
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