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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:  12/17/1998
 
Trade Name:  Ziagen
 
Generic Name or Proper Name (*):  abacavir
 
Indications Studied:  HIV infection
 
Label Changes Summary:  * Labeling for 3 months - 12 years * Information on dose, efficacy, PK parameters and AE profile
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  GlaxoSmithKline
 
Pediatric Exclusivity Granted Date:  12/14/1998
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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