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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
Sponsor:  Novartis
Pediatric Exclusivity Granted Date:  12/21/2007
Therapeutic Category:  Bone density