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:
11/21/2018
Trade Name:
Spy Agent Green
Generic Name or Proper Name (*):
Indocyanine green
Indications Studied:
Visualization of vessels, blood flow and tissue perfusion before, during, and after various surgical procedures, including minimally invasive surgeries and visualization of extrahepatic biliary ducts
Label Changes Summary:
*Use for visualization of vessels, blood flow and tissue perfusion has been established in pediatric patients one month and older. *Pediatric use for visualization of vessels, blood flow and tissue perfusion is supported by published data in 49 pediatric patients who received indocyanine green for assessment of blood flow and tissue perfusion in cardiovascular, vascular and plastic, micro and reconstructive procedures, and by clinical trials in adults. *Use for visualization of extrahepatic biliary ducts has been established in pediatric patients aged 12 to 17 years. *Pediatric use for visualization of extrahepatic biliary ducts is supported by clinical trials in adults in addition to clinical use in pediatric patients. *Use of indocyanine green for visualization of extrahepatic biliary ducts has not been established in pediatric patients less 12 years of age. *Safety and efficacy of indocyanine green for visualization of lymph nodes and lymphatic vessels during lymphatic mapping for cervical and uterine tumors has not been established in pediatric patients. *Information on dosing. *New indication and a new route of administration.
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Novadaq Technologies
NNPS:
FALSE
Therapeutic Category:
Medical imaging
-
-