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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:  04/07/2017
 
Trade Name:  Sovaldi
 
Generic Name or Proper Name (*):  sofosbuvir
 
Indications Studied:  In combination with ribavirin for the treatment of chronic hepatitis C virus genotype 2 or 3 infection without cirrhosis or with compensated cirrhosis in pediatric patients 12 to 17 years of age or weighing at least 35 kg
 
Label Changes Summary:  *Expanded the indication from adults to pediatric patients 12 years and older or weighing at least 35 kg. *Sovaldi was evaluated in an open-label clinical trial which included 50 patients 12 years of age and older. *Safety and efficacy have not been established in pediatric patients less than 12 years of age and weighing less than 35 kg with HCV genotype 2 or 3. Safety and efficacy have not been established in pediatric patients with HCV genotype 1 or 4. *Adverse reactions were similar to those observed in adults. *Information on dosing,clinical trial, and PK.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Gilead Sciences
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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