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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:
10/01/2019
Trade Name:
Entresto
Generic Name or Proper Name (*):
sacubitril/valsartan
Indications Studied:
Treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older
Label Changes Summary:
*Safety and effectiveness in pediatric heart failure patients 1 to <18 years old are supported by the reduction from baseline to 12 weeks in NT-proBNP in a randomized, double-blind clinical study [see Clinical Studies (14.2)]. The analysis of NT-proBNP included 90 patients age 6 to 18 years and 20 patients age 1 to 6 years. *Safety and effectiveness have not been established in pediatric patients less than 1 year of age. *Adverse reactions were similar to those observed in adults. *Information on dosing, PK parameters, clinical trial, and preparation of oral solution. *New indication.
BPCA(B) and PREA(P):
B,P
Sponsor:
Novartis Pharmaceuticals Corporation
Pediatric Exclusivity Granted Date:
09/26/2019
NNPS:
FALSE
Therapeutic Category:
Heart failure
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