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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:  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
Therapeutic Category:  Heart failure