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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
Therapeutic Category:  Antiviral