Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
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
BPCA(B) and PREA(P):
B, P
Sponsor:
Pfizer
Pediatric Exclusivity Granted Date:
09/04/2003
NNPS:
FALSE'
Therapeutic Category:
Antiviral
-
-