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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:  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  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Procter & Gamble
 
Pediatric Exclusivity Granted Date:  04/24/2009
 
NNPS:  FALSE
 
Therapeutic Category:  Bone density
 
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