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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 #:  3
Study Type:  Efficacy/Safety
Study Design:  Single-Blind/Placebo
No Patients:  152
No Centers:  11
No Countries:  1