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Fosamax will not face questions about increased fractures, FDA backgrounder indicates.Page 2

Executive Summary

FOSAMAX BACKGROUNDER FOR ADVISORY COMMITTEE REVIEW on July 13 notes that findings from four controlled studies on 1,541 postmenopausal women provide "assurance that alendronate does not have a deleterious effect on fractures." That assessment by FDA going into the meeting indicates that Merck's alendronate should not run into the problem of increased fractures in the treatment groups which sidetracked Procter & Gamble's etidronate application at its first review in March 1991.
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