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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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