The U.S. Food and Drug Administration has approved Rockwell Medical Inc.'s supplemental abbreviated new drug application to manufacture Calcitriol, a generic active vitamin D drug.
Calcitriol injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels
"Achieving this FDA approval is a significant achievement for Rockwell and it enables us to execute on our strategic initiative to begin selling Calcitriol in the renal market, where the CMS bundled-reimbursement payment system has incentivized dialysis service providers to utilize the lowest cost drugs," said Robert Chioini, CEO and chairman of Rockwell.
Chioini said Rockwell is planning to commercially launch the drug by the end of 2014.
"Rockwell's Calcitriol injection is the only one available packaged in vials, which is the standard of care, and it is equivalent in safety and efficacy to the branded vitamin D drugs," said Chioini.