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:
07/23/2009
Trade Name:
Actonel
Generic Name or Proper Name (*):
risedronate
Indications Studied:
Osteogenesis imperfecta
Label Changes Summary:
Safety and effectiveness have not been established in pediatric patients In a 1 year double-blind, placebo controlled study of pediatric patients with osteogenesis imperfecta (OI), treatment with risedronate did not result in a reduction in the risk of fracture Adverse events similar to those observed in adults except for an increased incidence in vomiting Information on clinical study
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Procter & Gamble
Pediatric Exclusivity Granted Date:
04/24/2009
NNPS:
FALSE'
Therapeutic Category:
Bone density
-
-