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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:
07/31/2018
Trade Name:
Granix injection
Generic Name or Proper Name (*):
tbo-filgrastim
Indications Studied:
Reduce the duration of severe neutropenia in pediatric patients 1 month and older with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia
Label Changes Summary:
*Safety and effectiveness have been established for pediatric patients 1 month to < 17 years old (no data for the age group < 1 month old). * Use in these age groups is supported by evidence from adequate and well-controlled studies in adults with additional safety and pharmacokinetics data from a single-arm trial of 50 pediatric patients with solid tumors treated with Granix for chemotherapy-induced neutropenia. *The safety profile in the pediatric population is similar to those observed in adults. *Information on adverse reactions, PK parameters, and clinical trial. *Postmarketing study.
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B,P
Sponsor:
Sicor Biotech UAB
Pediatric Exclusivity Granted Date:
07/18/2018
NNPS:
FALSE
Therapeutic Category:
Leukocyte growth factor
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