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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:  12/16/2016
 
Trade Name:  Tresiba
 
Generic Name or Proper Name (*):  insulin degludec
 
Indications Studied:  Improve glycemic control in type 1 and type 2 diabetes mellitus in pediatric patients 1 year and older
 
Label Changes Summary:  *Expanded indication from adults to pediatric patients 1 year and older. *Use in pediatric patients 1 year and older with type 1 and type 2 diabetes mellitus is supported by evidence from an adequate and well-controlled study and a pharmacokinetic study. Use in pediatric patients 1 year and older with type 2 diabetes mellitus is also supported by evidence from adequate and well-controlled studies in adults with type 2 diabetes mellitus. *Safety and effectiveness have not been established in pediatric patients less than 1 year old. *Adverse reactions similar to those observed in adults. *Information on dosing, PK, and clinical trials. *Postmarketing study.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Novo Nordisk
 
NNPS:  FALSE
 
Therapeutic Category:  Antidiabetic
 
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