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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:  10/24/2008
Trade Name:  Apidra
Generic Name or Proper Name (*):  insulin glulisine recombinant
Indications Studied:  Diabetes Mellitus
Label Changes Summary:  * Extended indication from adults to pediatric patients 4 years and older with type 1 diabetes * Has not been studied in pediatric patients less than 4 years with type 1 diabetes and in pediatric patients with type 2 diabetes * Pediatric patients had a higher incidence of severe symptomatic hypoglycemia compared to adults in the clinical study * New indication
Product Labeling:  Labeling  Opens a new window
Sponsor:  Sanofi-Aventis
Therapeutic Category:  Antidiabetic