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:
07/18/2007
Trade Name:
Toprol XL
Generic Name or Proper Name (*):
metoprolol
Indications Studied:
Hypertension
Label Changes Summary:
A study in 144 pediatric hypertensive pediatric patients aged 6 - 16 years did not meet its primary endpoint. However, some study endpoints demonstrated effectiveness Adverse event profile similar to adults Safety and effectiveness have not been established in patients < 6 years of age Information on PK parameters, clinical studies, and dose
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
AstraZeneca
Pediatric Exclusivity Granted Date:
07/27/2006
NNPS:
FALSE'
Therapeutic Category:
Antihypertensive
-
-