• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

  • Print
  • Share
  • E-mail
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  Opens a new window
Sponsor:  Vyteris
Therapeutic Category:  Anesthetic, topical