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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:  12/19/2019
 
Trade Name:  Fiasp
 
Generic Name or Proper Name (*):  insulin aspart
 
Indications Studied:  Diabetes mellitus in pediatric patients
 
Label Changes Summary:  *Safety and effectiveness have been established to improve glycemic control in pediatric patients with diabetes mellitus. *Use for this indication is supported by evidence from an adequate and well-controlled study in 777 pediatric patients with type 1 diabetes mellitus aged 2 to 17 years, and from studies in adults with diabetes mellitus. *Pediatric patients with type 1 diabetes treated with mealtime and postmeal FIASP reported a higher rate of blood glucose confirmed hypoglycemic episodes compared to patients treated with NovoLog; the imbalance was greater during the nocturnal period. *Monitor blood glucose levels closely in pediatric patients. *Information on dosing, adverse reactions, PK parameters and clinical trials. *Postmarketing study.
 
PREA(P):  P
 
Sponsor:  Novo Nordisk, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Antidiabetic
 
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