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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:  06/17/2019
 
Trade Name:  Victoza
 
Generic Name or Proper Name (*):  liraglutide
 
Indications Studied:  Treatment of type 2 diabetes mellitus in pediatric patients ages 10 years and older
 
Label Changes Summary:  *Safety and effectiveness as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes mellitus have been established in pediatric patients 10 years of age and older. *Use for this indication is supported by a 26-week placebo-controlled clinical trial and a 26-week open-label extension in 134 pediatric patients 10 to 17 years with type 2 diabetes, a pediatric pharmacokinetic study, and studies in adults with type 2 diabetes mellitus. *Safety and effectiveness have not been established in pediatric patients less than 10 years of age. *The risk of hypoglycemia was higher with Victoza in pediatric patients regardless of concomitant antidiabetic therapies. *Information on dosing, adverse reactions, PK parameters, and clinical trials. *Postmarketing study.
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  Novo Nordisk
 
Pediatric Exclusivity Granted Date:  05/01/2019
 
NNPS:  FALSE
 
Therapeutic Category:  Antidiabetic
 
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