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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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