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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
PREA(P):
P
Sponsor:
GlaxoSmithKline
NNPS:
FALSE'
Therapeutic Category:
Antiviral
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