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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:
05/16/2019
Trade Name:
Livalo
Generic Name or Proper Name (*):
pitavastatin
Indications Studied:
Heterozygous familial hypercholesterolemia (HeFH) to reduce elevated TC, LDL-C, and Apo B in pediatric patients 8 years and older
Label Changes Summary:
*Safety and effectiveness of LIVALO as an adjunctive therapy to diet to reduce elevated TC, LDL-C, and Apo B in pediatric patients aged 8 years and older with HeFH have been established. *Use of LIVALO for this indication is supported by a 12-week, double-blind, placebo-controlled trial in 82 pediatric patients 8 to 16 years of age with HeFH and a 52-week open-label trial in 85 pediatric patients with HeFH. *Safety and effectiveness have not been established in pediatric patients younger than 8 years with HeFH or in pediatric patients with other types of hyperlipidemia (other than HeFH). *Adverse reactions in pediatric patients were similar to those observed in adults. *Information on dosing, adverse reactions, clinical trial
PREA(P):
P
Sponsor:
Kowa Pharmaceuticals America, Inc.
NNPS:
FALSE
Therapeutic Category:
Antilipemic
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