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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:  03/18/2016
 
Trade Name:  OraVerse Injection
 
Generic Name or Proper Name (*):  phentolamine mesylate
 
Indications Studied:  Reversal of soft-tissue anesthesia
 
Label Changes Summary:  * Expanded indication down to pediatric patients 3 years and older; previously approved in 6 years and older. * Safety and efficacy have not been established in patients younger than 3 years. • Information on dosing and PK. * Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Septodent Holding SAS
 
NNPS:  FALSE
 
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