Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
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
PREA(P):
P
Sponsor:
Sanofi-Aventis
NNPS:
FALSE'
Therapeutic Category:
Antidiabetic
-
-