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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:  12/21/2005
 
Trade Name:  Fosamax
 
Generic Name or Proper Name (*):  alendronate
 
Indications Studied:  Severe osteogenesis imperfecta
 
Label Changes Summary:  Alendronate is not indicated for use in children The efficacy and safety were examined in a randomized, double-blind, placebo-controlled two-year study of 139 patients, 4-18 years old, with severe osteogenesis imperfecta Treatment with alendronate did not reduce the risk of fracture There were no statistically significant differences between the alendronate and placebo groups in reduction of bone pain Information on PK parameters, AE profile, and clinical studies
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Merck
 
Pediatric Exclusivity Granted Date:  04/28/2003
 
NNPS:  FALSE'
 
Therapeutic Category:  Bone density
 
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