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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
Sponsor:  Novo Nordisk
Pediatric Exclusivity Granted Date:  05/24/2005
Therapeutic Category:  Antidiabetic