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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:  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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