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:
03/10/2016
Trade Name:
Truvada
Generic Name or Proper Name (*):
emtricitabine/tenofovir disoproxil fumarate
Indications Studied:
Treatment of HIV-1 infection in pediatric patients weighing at least 17 kilograms
Label Changes Summary:
* Expanded the indication from pediatric patients 12 years and older down to pediatric patients weighing at least 17 kg. * Truvada should only be administered to HIV-1 infected pediatric patients with body weight greater than or equal to 17 kg and who are able to swallow a whole tablet. *Truvada has not been evaluated for use in pediatric patients weighing less than 17 kg. *Postmarketing study
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Gilead Sciences
NNPS:
FALSE
Therapeutic Category:
Antiviral
-
-