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Bone Care Hectorol sNDA "approvable"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Bone Care International is preparing a written response to FDA's Oct. 25 "approvable" letter for Hectorol (doxercalciferol) capsules. Approval depends on "satisfactory response" to questions about the firm's clinical trial and agreement on labeling. The sNDA covers secondary hyperparathyroidism in chronic kidney disease patients prior to dialysis. Hectorol is currently approved for chronic renal dialysis patients. Bone Care says it does not intend to seek the indication for its injectable Hectorol formulatio
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