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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
Sponsor:  GlaxoSmithKline
Pediatric Exclusivity Granted Date:  09/22/2000
Therapeutic Category:  Antiviral