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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:  03/19/2004
 
Trade Name:  Viracept
 
Generic Name or Proper Name (*):  nelfinavir
 
Indications Studied:  HIV-1
 
Label Changes Summary:  Safety and effectiveness established in patients 2  13 years of age New twice daily dosing regimen and modified three times daily dosing for pediatric patients > 2 years A reliably effective dose not established in patients <2 years of age PK information in pediatric patients from birth to 13 years of age Highly variable drug exposure is a significant problem in pediatric patients Adverse event profile was similar to that for adults
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Pfizer
 
Pediatric Exclusivity Granted Date:  09/04/2003
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiviral
 
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