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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:  06/14/2007
 
Trade Name:  Lexiva Oral Suspension
 
Generic Name or Proper Name (*):  fosamprenavir
 
Indications Studied:  Treatment of HIV infection in patients 2-18 years of age
 
Label Changes Summary:  * Effectiveness and safety were established in two clinical studies of pediatric patients 2-18 years of age * Adverse event profile is similar to that of adults with the exception of vomiting, which, regardless of causality, occurred more frequently among pediatric patients * Dosing information provided * Studies waived in children 0-1 month of age and deferred in children 1 month - 2 years of age * New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  GlaxoSmithKline
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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