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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  05/09/2008
 
Trade Name:  OraVerse Injection 0.4 mg (0.235 mg/mL)
 
Generic 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
 
Therapeutic Category:  Anesthetic, topical
 
Ages Studied:  3 years and older
 
Study #:  2
 
Study Type:  Efficacy/Safety/Pharmacodynamic
 
Study Design:  Single-Blind/Placebo
 
No Patients:  24
 
No Centers:  16
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
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