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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:  12/22/2006
Trade Name:  Emtriva
Generic Name or Proper Name (*):  emtricitabine
Indications Studied:  HIV-1 infection in combination with other antiretroviral agents
Label Changes Summary:  * Efficacy in preventing or treating HIV in neonates to 3 month olds could not be determined after a PK study in 20 neonates born to HIV positive mothers * Information on dose in 0-3 months, additional safety and PK parameters
Product Labeling:  Labeling  Opens a new window
BPCA(B) and PREA(P):  B, P
Sponsor:  Gilead Sciences
Pediatric Exclusivity Granted Date:  05/24/2006
Therapeutic Category:  Antiviral