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New Pediatric Labeling Information Database - Detail
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Pediatrics
New Pediatric Labeling Information Database
Detail
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Pediatric Labeling Date:
11/22/2013
Trade Name:
Nitropress
Generic Name or Proper Name (*):
sodium nitroprusside
Indications Studied:
Immediate reduction of blood pressure in hypertensive crisis
Label Changes Summary:
*Efficacy in the pediatric population was established based on adult trials and supported by a dose-ranging trial and an open label trial that achieved adequate mean arterial pressure control in pediatric patients. *No novel safety issues were found in these two studies. *Information on dosing, PK parameters and clinical trials. *Off-patent Written Request.
BPCA(B):
B
Sponsor:
Hospira
NNPS:
FALSE
Therapeutic Category:
Antihypertensive
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