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:
02/04/2010
Trade Name:
Benicar
Generic Name or Proper Name (*):
olmesartan
Indications Studied:
Hypertension
Label Changes Summary:
Expanded indication from adults to pediatric patients 6 years and older Information on preparation of an oral suspension Adverse events similar to adult patients Information on dosing, adverse reactions, pharmacokinetics, and clinical studies
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
Daiichi Sankyo
Pediatric Exclusivity Granted Date:
10/07/2009
NNPS:
FALSE'
Therapeutic Category:
Antihypertensive
-
-