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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:  11/14/2017
 
Trade Name:  Fasenra
 
Generic Name or Proper Name (*):  benralizumab
 
Indications Studied:  Add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype
 
Label Changes Summary:  *Indicated in pediatric patients 12 years and older. *There were 108 adolescents aged 12 to 17 with asthma enrolled in the two Phase 3 exacerbation trials. *Safety and efficacy in patients younger than 12 years of age has not been established. *Adverse reactions were similar to those observed in adults. *Information on dosing, adverse reactions, PK parameters, and clinical trials. *New drug.
 
PREA(P):  P
 
Sponsor:  AstraZeneca
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic
 
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