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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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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
 
PREA(P):  P
 
Sponsor:  Vyteris
 
NNPS:  FALSE
 
Therapeutic Category:  Anesthetic, topical
 
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