• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

  • Print
  • Share
  • E-mail
-
 
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
 
-
-