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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:  10/08/2002
 
Trade Name:  Epivir
 
Generic Name or Proper Name (*):  lamivudine
 
Indications Studied:  HIV
 
Label Changes Summary:  Lamivudine clearance substantially reduced in 1-week-old neonates relative to pediatric patients >3 months of age
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  GlaxoSmithKline
 
Pediatric Exclusivity Granted Date:  09/22/2000
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiviral
 
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