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:
03/20/2008
Trade Name:
Zometa
Generic Name or Proper Name (*):
zoledronic acid
Indications Studied:
Severe osteogenesis imperfecta
Label Changes Summary:
Zoledronic acid is not indicated for use in children Safety and effectiveness was studied in 152 pediatric patients with severe osteogenesis imperfecta aged 1 - 17 years. At one year, increases in BMD were observed in the zoledronic acid treatment group but the changes did not necessarily correlate with the risk for fracture or the incidence or severity of chronic bone pain Information on PK, clinical study, and AE profile
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Novartis
Pediatric Exclusivity Granted Date:
12/21/2007
NNPS:
FALSE'
Therapeutic Category:
Bone density
-
-