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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:  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.
Sponsor:  Abraxis BioScience, L.L.C.
Pediatric Exclusivity Granted Date:  11/08/2019
Therapeutic Category:  Antineoplastic