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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:  09/13/2005
 
Trade Name:  NovoLog
 
Generic Name or Proper Name (*):  insulin aspart recombinant injection
 
Indications Studied:  Diabetes Mellitus
 
Label Changes Summary:  * In clinical studies comparing NovoLog to regular human insulin in patients 2 to 18 years with type 1 diabetes, NovoLog achieved glycemic control comparable to regular human insulin * The incidence of hypoglycemia was similar for both treatment groups
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Novo Nordisk
 
Pediatric Exclusivity Granted Date:  05/24/2005
 
NNPS:  FALSE
 
Therapeutic Category:  Antidiabetic
 
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