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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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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  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Novartis
 
Pediatric Exclusivity Granted Date:  12/21/2007
 
NNPS:  FALSE
 
Therapeutic Category:  Bone density
 
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