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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:  03/14/2008
 
Trade Name:  NovoLog
 
Generic Name or Proper Name (*):  insulin aspart [rDNA origin] injection
 
Indications Studied:  Insulin analog indicated to improve glycemic control
 
Label Changes Summary:  * Efficacy was demonstrated in a clinical study with pediatric patients ages 4 to 18 years using an external insulin pump * New dosing regimen
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Novo Nordisk
 
NNPS:  FALSE
 
Therapeutic Category:  Antidiabetic
 
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