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:
09/29/2006
Trade Name:
Fuzeon
Generic Name or Proper Name (*):
enfuvirtide
Indications Studied:
HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy
Label Changes Summary:
Additional safety and efficacy data and AE information from clinical study in 5-16 year olds Insufficient data to provide dosing recommendations in patients < 6 years
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
Hoffmann-La Roche
NNPS:
FALSE'
Therapeutic Category:
Antiviral
-
-