• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

  • Print
  • Share
  • E-mail
-
 
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
 
-
-