Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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:  06/29/2016
 
Trade Name:  Kovanaze Nasal Spray
 
Generic Name or Proper Name (*):  tetracaine HCl and oxymetazoline HCl
 
Indications Studied:  Regional anesthesia when performing a restorative procedure on teeth 4-13 and A-J in adults and children who weigh 40 kg or more
 
Label Changes Summary:  *Approved in adults and children who weigh 40 kg or more *Kovanaze has not been studied in pediatric patients under 3 years and is not advised for use in pediatric patients weighing less than 40 kg because efficacy has not been demonstrated in these patients *Information on adverse reactions in adults and pediatric patients, clinical trial, PK * New drug
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  St. Renatus, LLC
 
NNPS:  FALSE
 
Therapeutic Category:  Anesthetic, topical
 
-
-