Bone Care Hectorol I.V. Approval Followed FDA Reconsideration Of Control
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Using dialysis patients as their own controls is a "reasonable and sound approach" to assess the efficacy of intravenous Hectorol (doxercalciferol), Division of Metabolic and Endocrine Drug Products (DMEDP) Deputy Director Lisa Rarick, MD, said in recommending approval of the vitamin D analog.