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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:  08/16/2012
 
Trade Name:  Viread
 
Generic Name or Proper Name (*):  tenofovir disoproxil fumarate
 
Indications Studied:  Treatment of chronic hepatitis B
 
Label Changes Summary:  *Expanded the indication from adults to pediatric patients 12 - < 18 years of age, weighing at least 35k*Safety and efficacy in pediatric patients with chronic hepatitis B < 12 years old or weighing < 35 kg have not been established *In a clinical trial in pediatric patients 12 - <18 years, the mean rate of bone mineral density gain was less in Viread-treated patients compared to placebo* Information on dosing, adverse reactions, and clinical trial *Postmarketing study
 
Product Labeling:  >http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021356s042,022577s002lbl.pdf  Opens a new window
 
PREA(P):  P
 
Sponsor:  Gilead
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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