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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:  10/24/2018
 
Trade Name:  Xofluza
 
Generic Name or Proper Name (*):  baloxavir marboxil
 
Indications Studied:  Treatment of acute uncomplicated influenza in patients 12 years and older who have been symptomatic for no more than 48 hours
 
Label Changes Summary:  *Safety and effectiveness for the treatment of influenza have been established in adults and pediatric patients 12 years and older weighing at least 40 kg. *Safety and effectiveness have not been established in pediatric patients less than 12 years. *Use in pediatric patients 12 years and older weighing at least 40 kg is supported by one randomized, double-blind, controlled trial in which 118 adolescents were randomized to receive either Xofluza (N=80) or placebo (N=38). The median time to alleviation of symptoms in adolescent subjects was 54 hours compared to 93 hours for subjects who received placebo. *Adverse reactions reported in adolescents were similar to those reported in adults. *Information on dosing, adverse reactions, clinical trial and PK parameters in adults and pediatric patients 12 years and older. *New drug.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Shionogi
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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