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:
12/20/2001
Trade Name:
Alphagan
Generic Name or Proper Name (*):
brimonidine
Indications Studied:
Prevention of post-operative IOP elevations
Label Changes Summary:
Safety and effectiveness established down to 2 years Somnolence in patients 2 to 6 years (50-83%) versus patients 7 years of age or older (25%)
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Allergan
Pediatric Exclusivity Granted Date:
10/10/2001
NNPS:
FALSE'
Therapeutic Category:
Ophthalmologic hypotensive
-
-