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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:  05/09/2008
 
Trade Name:  OraVerse Injection 0.4 mg (0.235 mg/mL)
 
Generic Name or Proper Name (*):  phentolamine mesylate
 
Indications Studied:  Reversal of soft-tissue anesthesia, i.e., anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic containing a vasoconstrictor
 
Label Changes Summary:  Use in children less than 6 years of age or weighing less than 15 kg (33 lbs) is not recommended Dosing information provided for children weighing 15 to 30 kg (66 lbs) Safety and efficacy were established in 2 clinical trials in children 12 to 17 years old, one trial in children ages 6 to 11 years, as well as adult studies Safety has been evaluated in pediatric patients under the age of 6 years but not efficacy Pharmacokinetics have been evaluated in children weighing 15 kg or more New indication
 
PREA(P):  P
 
Sponsor:  Novalar Pharmaceuticals, Inc.
 
NNPS:  FALSE'
 
Therapeutic Category:  Anesthetic, topical
 
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