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:
05/06/2004
Trade Name:
Lidosite Topical System Kit
Generic Name or Proper Name (*):
epinephrine; lidocaine
Indications Studied:
Topical local analgesia for superficial dermatological procedures in children 5 years of age and older
Label Changes Summary:
505(b)(2) with clinical studies Safety and effectiveness established in studies of pediatric patients 5-18 years of age PK study in pediatric patients 6-15 years of age dosing regimen established in clinical trials Studies in patients 0-5 years of age deferred New dosage form; new route of administration
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Vyteris
NNPS:
FALSE'
Therapeutic Category:
Anesthetic, topical
-
-