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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:  12/19/2008
 
Trade Name:  Ziagen
 
Generic Name or Proper Name (*):  abacavir
 
Indications Studied:  HIV infection
 
Label Changes Summary:  Provided new scored tablet for use in pediatric patients weighing >14 kg who can swallow tablets New dosing regimen
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  GlaxoSmithKline
 
Pediatric Exclusivity Granted Date:  12/14/1998
 
NNPS:  TRUE'
 
Therapeutic Category:  Antiviral
 
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