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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
Therapeutic Category:  Antiviral