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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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