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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:  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  Opens a new window
 
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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