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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:  09/28/2005
 
Trade Name:  Emtriva
 
Generic Name or Proper Name (*):  emtricitabine
 
Indications Studied:  HIV-1 infection in combination with other antiretroviral agents
 
Label Changes Summary:  Safety and effectiveness in pediatric patients 3 months and older supported by data from 3 open-label, nonrandomized clinical studies Safety and effectiveness in patients < 3 months have not been established Relative bioavailability of Emtriva oral solution is approximately 80% of Emtriva capsules. Thus, maximum dosage is different for these 2 formulations: Solution max - 240 mg once daily; Capsules max - children weighing > 33 kg one 200 mg capsule once daily The AE profile in pediatric patients was comparable to that observed in adults Information on dose, PK parameters, AE profile and clinical studies
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Gilead Sciences
 
Pediatric Exclusivity Granted Date:  05/24/2006
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiviral
 
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