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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:  06/17/2013
 
Trade Name:  Precedex
 
Generic Name or Proper Name (*):  dexmedetomidine hydrochloride
 
Indications Studied:  Loading and maintenance infusion for sedation in intubated and mechanically ventilated pediatric patients
 
Label Changes Summary:  *Safety and efficacy have not been established for procedural or ICU sedation in pediatric patients *One assessor-blinded trial in pediatric patients and two open label studies in neonates were conducted to assess efficacy for ICU sedation. These studies did not meet their primary efficacy endpoints and the safety data submitted were insufficient to fully characterize the safety profile of dexmedetomidine for this patient population *Use for procedural sedation in pediatric patients has not been evaluated
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Hospira
 
Pediatric Exclusivity Granted Date:  03/12/2013
 
NNPS:  FALSE
 
Therapeutic Category:  Sedative
 
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